<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01696279</url>
  </required_header>
  <id_info>
    <org_study_id>SPD405-207</org_study_id>
    <secondary_id>2012-000171-17</secondary_id>
    <nct_id>NCT01696279</nct_id>
  </id_info>
  <brief_title>A Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Investigate and Compare the Efficacy, Safety and Tolerability of Lanthanum Carbonate With Calcium Carbonate in Hyperphosphataemic Children and Adolescents With Chronic Kidney Disease on Dialysis</brief_title>
  <official_title>A 3-part Open-label Study to Assess the Pharmacokinetics of Lanthanum Carbonate, Compare the Efficacy, Safety and Tolerability of 8 Weeks of Treatment With Lanthanum Carbonate and Calcium Carbonate Using a Crossover Design and Investigate the Efficacy and Safety of 8 Months of Treatment With Lanthanum Carbonate in Hyperphosphataemic Children and Adolescents Aged 10 Years to &lt;18 Years With Chronic Kidney Disease on Dialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shire</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to summarize the percentage of participants achieving&#xD;
      age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus&#xD;
      in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on&#xD;
      dialysis, following 8 weeks of treatment with lanthanum carbonate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 15, 2013</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)</measure>
    <time_frame>After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
    <description>KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (&gt;=) 12 to less than (&lt;) 18 years to be less than or equal to (&lt;=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2</measure>
    <time_frame>Up to 19 weeks</time_frame>
    <description>KDOQI serum phosphorus targets was defined for: Adolescents aged &gt;= 12 &lt; 18 years to be &lt;= 5.5 mg/dL (1.78 [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks</measure>
    <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
    <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8</measure>
    <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
    <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8</measure>
    <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
    <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol^2/L^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</measure>
    <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
    <description>Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</measure>
    <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
    <description>Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</measure>
    <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
    <description>Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemical Bone Markers</measure>
    <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)</measure>
    <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)</measure>
    <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)</measure>
    <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Biochemical Bone Markers for Fetuin-A</measure>
    <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Height</measure>
    <time_frame>Baseline, Week 8, Week 16, and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Weight</measure>
    <time_frame>Baseline, Week 8, Week 16, and EOS (up to 42 weeks)</time_frame>
    <description>Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">63</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>Lanthanum Carbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium Carbonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanthanum Carbonate</intervention_name>
    <description>Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.</description>
    <arm_group_label>Lanthanum Carbonate</arm_group_label>
    <other_name>SPD405</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Carbonate</intervention_name>
    <description>Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.</description>
    <arm_group_label>Calcium Carbonate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 10 years to less than (&lt;) 18 years of age at the time of consent.&#xD;
&#xD;
          2. Participant or parent/legally authorized representative (LAR) understand and are able,&#xD;
             willing, and likely to fully comply with the study procedures and restrictions defined&#xD;
             in this protocol.&#xD;
&#xD;
          3. Male, or non-pregnant, non-lactating female who agrees to comply with any applicable&#xD;
             contraceptive requirements of the protocol.&#xD;
&#xD;
          4. Established chronic kidney disease (CKD), on dialysis, and requires treatment for&#xD;
             hyperphosphatemia with a phosphate binder.&#xD;
&#xD;
          5. Serum phosphorus levels after a washout period of up to 3 weeks as follows: Age &lt;12&#xD;
             years: Serum phosphorus greater than (&gt;) 6.0 mg/dL (1.94 mmol/L); Age 12 years and&#xD;
             older: Serum phosphorus &gt;5.5mg/dL (1.78mmol/L).&#xD;
&#xD;
          6. Ability to provide written, signed and dated (personally or via an LAR) informed&#xD;
             consent/and assent, as applicable, to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or recurrent disease (example [eg], cardiovascular, liver, unstable and&#xD;
             uncontrolled gastrointestinal, malignancy, or other conditions) other than CKD or&#xD;
             end-stage renal disease that could affect the action, absorption or disposition of the&#xD;
             investigational product, or clinical or laboratory assessments.&#xD;
&#xD;
          2. Current or relevant history of physical or psychiatric illness, any medical disorder&#xD;
             (except for CKD or end-stage renal disease and related co-morbidities) that may&#xD;
             require treatment or make the participant unlikely to fully complete the study, or any&#xD;
             condition that presents undue risk from the investigational product or procedures.&#xD;
&#xD;
          3. Unable to eat semi-solid foods or on Total Enteral Alimentation.&#xD;
&#xD;
          4. Known or suspected intolerance or hypersensitivity to the investigational product(s),&#xD;
             closely related compounds, or any of the stated ingredients.&#xD;
&#xD;
          5. History of alcohol or other substance abuse within the last year.&#xD;
&#xD;
          6. Current use of any medication (including over-the-counter, herbal, or homeopathic&#xD;
             preparations) that could affect (improve or worsen) the condition being studied, or&#xD;
             could affect the action, absorption, or disposition of the investigational product(s),&#xD;
             or clinical or laboratory assessment.&#xD;
&#xD;
          7. Weight and age of participant are outside of local applicable criteria for blood&#xD;
             sample volume limits.&#xD;
&#xD;
          8. Use of another investigational product within 30 days prior to receiving the first&#xD;
             dose of investigational product.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Infantil Del Rinon S.R.L</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>4000</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Luis Calvo Mackenna</name>
      <address>
        <city>Santiago</city>
        <zip>7500539</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Dr. Sotero del Rio</name>
      <address>
        <city>Santiago</city>
        <zip>8207257</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>70852</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Motol</name>
      <address>
        <city>Prague 5</city>
        <zip>15006</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinder-und Jugendklinik Erlangen</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem Altalanos Orvostudomanyi Kar</name>
      <address>
        <city>Budapest</city>
        <state>Bokay Janos</state>
        <zip>1083</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum</name>
      <address>
        <city>Debrecen</city>
        <zip>4032</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar</name>
      <address>
        <city>Szeged</city>
        <zip>6720</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Dzieciecy Szpital Kliniczny</name>
      <address>
        <city>Bialystok</city>
        <zip>15-274</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Dzieciecy w Krakowie, Klinika Nefrologii Dzieciecej ze Stacja Dializ</name>
      <address>
        <city>Krakow</city>
        <zip>30663</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NZOZ tri-Medica</name>
      <address>
        <city>Lodz</city>
        <zip>93-338</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny</name>
      <address>
        <city>Wroclaw</city>
        <zip>50556</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Urgenta pentru Copii Sf. Maria</name>
      <address>
        <city>Iasi</city>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Spitalul Clinic de Urgenta pentru Copii - Louis Turcanu</name>
      <address>
        <city>Timisoara</city>
        <zip>300350</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children City Clinical Hospital of Saint Vladimir</name>
      <address>
        <city>Moscow</city>
        <zip>107014</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Petersburg State Budgetary Healthcare Institution &quot;Children City Hospital #1&quot;</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>198205</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>State Budgetary Healthcare Instit. of Sverdiov Region &quot;Regional Children Clinical Hosp #1&quot;</name>
      <address>
        <city>Yekaterinburg</city>
        <zip>620143</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cukurova University Faculty of Medicine Paediatric Nephrology</name>
      <address>
        <city>Adana</city>
        <zip>01330</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Izmir Tepecik Training and Research Hospital</name>
      <address>
        <city>Izmir</city>
        <zip>4500</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manisa Celal Bayar University Hafsa Sultan Hospital</name>
      <address>
        <city>Manisa</city>
        <zip>45030</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Chile</country>
    <country>Czechia</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>Bulgaria</country>
    <country>Czech Republic</country>
    <country>South Africa</country>
  </removed_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <results_first_submitted>September 30, 2019</results_first_submitted>
  <results_first_submitted_qc>December 10, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 2, 2020</results_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Hyperphosphatemia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 18, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT01696279/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 14, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT01696279/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study was conducted at 23 study centers between 15 February 2013 (first participant first visit) and 16 November 2018 (last participant last visit).</recruitment_details>
      <pre_assignment_details>It was a 3 part study (Part 1: Pharmacokinetic assessment, Part 2: [Part 2a-calcium carbonate and lanthanum carbonate {crossover comparison} or Part 2b-lanthanum carbonate], Part 3: lanthanum carbonate treatment for 6 months). Overall 63 participants enrolled in the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Part 1: Single Dose Lanthanum Carbonate</title>
          <description>Participants aged 10 to 12 years received 500 milligram (mg) and greater than (&gt;) 12 years received 1000 mg single dose of lanthanum carbonate oral powder in the morning following breakfast.</description>
        </group>
        <group group_id="P2">
          <title>Part 2a: Calcium Carbonate, Then Lanthanum Carbonate (8 Weeks)</title>
          <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks calcium carbonate, followed by 3 weeks of washout period (if necessary). At the end of first 8-week treatment period of part 2a, participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks lanthanum carbonate treatment period.</description>
        </group>
        <group group_id="P3">
          <title>Part 2b: Lanthanum Carbonate (8 Weeks)</title>
          <description>Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).</description>
        </group>
        <group group_id="P4">
          <title>Part 3: Lanthanum Carbonate (6 Months)</title>
          <description>Participants who completed in Part 2 (2a or 2b) could continue to receive lanthanum carbonate for an additional 6 months. Dosage of lanthanum carbonate was determined by the investigator based on serum phosphate levels taken at each study visit up to a maximum dose of 3000 mg/day.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Part 1: Single Dose Lanthanum Carbonate</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set 1</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Entered Part 2a</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Kidney Transplant</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2a: Calcium Carbonate + Lanthanum</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="53">19 participants enrolled from Part 1 and 34 new participants enrolled in Part 2a</participants>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Completer Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="37"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="53"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Set 1</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Set 2</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Entered Part 3</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="34"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="19"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (Unspecified)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Kidney Transplant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Non-Compliance with Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 2b: Lanthanum Carbonate (8 Weeks)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9">9 new participants were enrolled in Part 2b</participants>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Completer Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Set 1</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Per-protocol Set 2</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="9"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="8"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Kidney Transplant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Part 3: Lanthanum Carbonate (6 Months)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="42">34 participants from Part 2a and 8 participants from Part 2b continued to Part 3</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="8"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Kidney transplant</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other (Unspecified)</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missing</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Safety analysis set 1 and 2 included all participants who had taken 1 dose of IP in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Few participants were analyzed in multiple arms/periods within the study, hence to avoid the duplication, baseline was analyzed only for the overall participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Overall Study</title>
          <description>Study was conducted in 3 parts, participants aged 10 to 12 years received 500 milligram (mg) and greater than (&gt;) 12 years received 1000 mg single dose of lanthanum carbonate oral powder respectively during part 1, followed by part 2 during which participants received calcium carbonate tablet for 8 weeks until a maximum daily dose of 6500 mg was reached (part 2a-Treatment period 1) and then received lanthanum carbonate oral powder for 8 weeks until a daily dose of 1500 mg was reached (part 2a-Treatment period 2). Eligible participants received lanthanum carbonate oral powder for 8 weeks at a daily dose of 1500 mg, which was titrated bi-weekly until a daily dose of 3000 mg was achieved (part 2b). Participants who completed part 2 continued the same treatment for additional 6 months during the part 3.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="63"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13.1" spread="2.65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Age group: &lt; 10 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age group: ≥10 to &lt;12 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age group: ≥12 to &lt;18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Age group: ≥18 years</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Multiple</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)</title>
        <description>KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (&gt;=) 12 to less than (&lt;) 18 years to be less than or equal to (&lt;=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
        <population>Per-protocol set 2 (PP2) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)</title>
          <description>KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (&gt;=) 12 to less than (&lt;) 18 years to be less than or equal to (&lt;=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>Per-protocol set 2 (PP2) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2</title>
        <description>KDOQI serum phosphorus targets was defined for: Adolescents aged &gt;= 12 &lt; 18 years to be &lt;= 5.5 mg/dL (1.78 [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Up to 19 weeks</time_frame>
        <population>Per Protocol Set 1 (PP1) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2</title>
          <description>KDOQI serum phosphorus targets was defined for: Adolescents aged &gt;= 12 &lt; 18 years to be &lt;= 5.5 mg/dL (1.78 [mmol/L]); Children aged &gt;=10 years to &lt;12 years to be &lt;= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>Per Protocol Set 1 (PP1) included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>Percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58.8"/>
                    <measurement group_id="O2" value="70.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks</title>
        <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks</title>
          <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimoles per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.334" spread="0.1035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8</title>
        <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8</title>
          <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.0363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8</title>
        <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol^2/L^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8</title>
          <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol^2/L^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>mmol^2/L^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.577" spread="0.2464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
        <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
          <description>Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.520" spread="0.1786"/>
                    <measurement group_id="O2" value="-0.467" spread="0.1312"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
        <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
          <description>Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.058" spread="0.0554"/>
                    <measurement group_id="O2" value="-0.009" spread="0.0574"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
        <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 2), also participants received lanthanum carbonate powder orally at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2b).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2</title>
          <description>Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>mmol^2/L^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="16"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.966" spread="0.4084"/>
                    <measurement group_id="O2" value="-0.669" spread="0.3834"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
        <description>Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
          <description>Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.334" spread="0.1035"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.416" spread="0.0912"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="27"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.314" spread="0.1278"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="25"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.316" spread="0.1055"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.322" spread="0.1356"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.236" spread="0.1491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.143" spread="0.1558"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
        <description>Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
          <description>Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>millimole per liter (mmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.001" spread="0.0363"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.045" spread="0.0475"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.034" spread="0.0534"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.003" spread="0.0511"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.0450"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.049" spread="0.0623"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.127" spread="0.0773"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
        <description>Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32</time_frame>
        <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3</title>
          <description>Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP2 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of treatment with lanthanum carbonate and who had serum phosphate assessment data available during Part 2 or Part 3 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>mmol^2/L^2</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.577" spread="0.2464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="28"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.783" spread="0.2535"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="26"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.575" spread="0.3023"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 20</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.362" spread="0.2711"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 24</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.578" spread="0.3459"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 28</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.326" spread="0.3767"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 32</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.570" spread="0.3624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemical Bone Markers</title>
        <description>Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemical Bone Markers</title>
          <description>Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>microgram per liter (ug/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALP : Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.78" spread="8.503"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP : Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="31.86" spread="16.334"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALP : Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="59.12" spread="20.822"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteocalcin: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2" spread="20.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteocalcin: Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="10.3" spread="21.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Osteocalcin: Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="94.0" spread="32.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sclerostin: Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.146" spread="0.1380"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sclerostin: Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.062" spread="0.0946"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sclerostin: Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-0.051" spread="0.1037"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)</title>
        <description>Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)</title>
          <description>Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>unit per liter (U/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.71" spread="1.141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.95" spread="1.173"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="4.65" spread="1.934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)</title>
        <description>Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)</title>
          <description>Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>relative unit per milliliter (RU/ml)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5130.3" spread="5232.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-8162.4" spread="5274.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="-251.1" spread="1736.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)</title>
        <description>Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)</title>
          <description>Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>picomole per litre (pmol/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="16"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.132" spread="9.7669"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="15"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="16.273" spread="12.5441"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="59.801" spread="16.3097"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Biochemical Bone Markers for Fetuin-A</title>
        <description>Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16 and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Biochemical Bone Markers for Fetuin-A</title>
          <description>Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>gram per liter (g/L)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Changed at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="12"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.006" spread="0.0301"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.037" spread="0.0360"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.039" spread="0.0273"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Height</title>
        <description>Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16, and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Height</title>
          <description>Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>centimeter (cm)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="0.6" spread="0.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.3" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Weight</title>
        <description>Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
        <time_frame>Baseline, Week 8, Week 16, and EOS (up to 42 weeks)</time_frame>
        <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
        <group_list>
          <group group_id="O1">
            <title>Part 2: Calcium Carbonate</title>
            <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
          </group>
          <group group_id="O2">
            <title>Part 2 + Part 3: Lanthanum Carbonate</title>
            <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Weight</title>
          <description>Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.</description>
          <population>PP1 included participants who had taken at least 1 dose of investigational product and completed 8 weeks of calcium carbonate followed by 8 weeks of lanthanum carbonate and who had serum phosphate assessment data available during Part 2 to allow summarizing the percentage of participants achieving age-specific KDOQI target.</population>
          <units>kilogram (Kg)</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
                <count group_id="O2" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="17"/>
                    <count group_id="O2" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.18" spread="0.524"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 16</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="17"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1.09" spread="0.358"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at EOS</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="0"/>
                    <count group_id="O2" value="13"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="2.86" spread="0.606"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From start of study drug administration up to 42 Weeks</time_frame>
      <desc>SAS1 and SAS2 included all participants who had taken 1 dose of investigational product in Part 1 for SAS 1, Part 2 or 3 for SAS 2 and who had completed at least 1 follow-up safety assessment. Data was presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for part 2 and 3 in the entire study and separately for Part 1.</desc>
      <group_list>
        <group group_id="E1">
          <title>Part 1: Lanthanum Carbonate</title>
          <description>Participants aged 10 to 12 years received 500 mg and greater than (&gt;) 12 years received 1000 mg single dose of lanthanum carbonate oral powder.</description>
        </group>
        <group group_id="E2">
          <title>Part 2: Calcium Carbonate</title>
          <description>Participants received calcium carbonate oral tablet until the target serum phosphorus level achieved or until a maximum daily dose of 6500 mg was reached and once serum phosphorus control was achieved the dose was maintained until the end of 8 weeks (Part 2a: treatment period 1).</description>
        </group>
        <group group_id="E3">
          <title>Part 2 + Part 3: Lanthanum Carbonate</title>
          <description>Participants received lanthanum carbonate powder at a daily dose of 1500 mg mixed into meals and given three times a day or twice daily with a single dose not exceeding 1000 mg, total daily dose was titrated bi-weekly until a maximum dose of 3000 mg was reached and once the serum phosphorus control was achieved the dose was maintained until the end of 8 weeks treatment period (Part 2a and Part 2b) and continued to receive lanthanum carbonate for additional 6 months (Part 3).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arrhythmia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Device occlusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Thrombosis in device</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatitis acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Appendicitis perforated</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Catheter site infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Device related infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Erysipelas</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Peritonitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous fistula site haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Arteriovenous fistula thrombosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Graft haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Humerus fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood phosphorus</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Fluid overload</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="3" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Metabolic disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Osteochondrosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 16.1</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="53"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="53"/>
                <counts group_id="E3" events="5" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="2" subjects_affected="1" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="5" subjects_affected="5" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="53"/>
                <counts group_id="E3" events="9" subjects_affected="5" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="6" subjects_affected="3" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="53"/>
                <counts group_id="E3" events="9" subjects_affected="6" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Somnolence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="20"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="53"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually</restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Data was analyzed and presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for Part 2 and 3 in the entire study and separately for Part 1.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Study Director</name_or_title>
      <organization>Shire</organization>
      <phone>+1 866 842 5335</phone>
      <email>ClinicalTransparency@shire.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01696279
org study id: SPD405-207
secondary id: 2012-000171-17
nct id: NCT01696279
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to summarize the percentage of participants achieving
      age-specific Kidney Disease Outcomes Quality Initiative (KDOQI) targets for serum phosphorus
      in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on
      dialysis, following 8 weeks of treatment with lanthanum carbonate.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level Following 8 Weeks of Lanthanum Carbonate Administration (Part 2 + Part 3)
time frame: After 8 weeks of lanthanum carbonate administration in Part 2 and/or in Part 3
description: KDOQI serum phosphorus targets were defined for: Adolescents aged greater than or equal to (>=) 12 to less than (<) 18 years to be less than or equal to (<=) 5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per liter [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level was reported only for the participants who had received lanthanum carbonate during part 2 or part 3. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Percentage of Participants Achieving Age-Specific Kidney Disease Outcomes Quality Initiative (KDOQI) Targets for Serum Phosphate Level During Part 2
time frame: Up to 19 weeks
description: KDOQI serum phosphorus targets was defined for: Adolescents aged >= 12 < 18 years to be <= 5.5 mg/dL (1.78 [mmol/L]); Children aged >=10 years to <12 years to be <= 6.0 mg/dL (1.94 mmol/L). Percentage of participants achieving age-specific KDOQI targets for serum phosphate level were reported only for the participants who had received calcium carbonate followed by 8 weeks of treatment with lanthanum carbonate in Part 2. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Serum Phosphorus Levels Following Treatment With Lanthanum Carbonate After 8 Weeks
time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
description: Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with chronic kidney disease (CKD) who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium Levels Following Treatment With Lanthanum Carbonate After Week 8
time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
description: Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Lanthanum Carbonate After Week 8
time frame: Baseline, Week 8 of lanthanum carbonate administration in Part 2 and/or in Part 3
description: Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with lanthanum carbonate for 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome measure was millimole square per square liter (mmol^2/L^2). Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Serum Phosphorus Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
time frame: Baseline, Week 8
description: Changes from baseline in serum phosphorus levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
time frame: Baseline, Week 8
description: Changes from baseline in calcium levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium-Phosphorus Product Levels Following Treatment With Calcium Carbonate After 8 Weeks and Lanthanum Carbonate After 8 Weeks During Part 2
time frame: Baseline, Week 8
description: Changes from baseline in calcium-phosphorus product levels in hyperphosphatemic children and adolescents with CKD who are on dialysis, following treatment with calcium carbonate after 8 weeks and lanthanum carbonate after 8 weeks were combined and reported. Baseline was defined as the last assessment prior to the first dose of investigational product. The unit of measure for this outcome was millimole square per square liter. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Serum Phosphorus Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
description: Change from baseline in serum phosphorus levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
description: Change from baseline in calcium levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6- month extension phase (Part 3) were reported.Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Calcium-Phosphorus Product Levels at the Last Visit of 8-Week Treatment Period in Part 2 and Monthly During 6-Month Extension Phase of Part 3
time frame: Baseline, Week 8, 12, 16, 20, 24, 28 and Week 32
description: Change from baseline in calcium-phosphorus product levels at the last visit of each 8-week treatment period during Part 2 and monthly during the 6-month extension phase (Part 3) were reported. Baseline was defined as the last assessment prior to the first dose of investigational product. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. The unit of measure of this outcome was millimole square per square liter. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Biochemical Bone Markers
time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
description: Change from baseline in bone turnover markers including bone alkaline phosphatase (ALP), osteocalcin, and sclerostin was reported for combined Part 2 and 3. End of the study (EOS) was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Biochemical Bone Markers for Tartrate-Resistant Acid Phosphatase (TRAP)
time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
description: Change from baseline in bone turnover markers for, tartrate-resistant acid phosphatase (TRAP) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Biochemical Bone Markers for Fibroblast Growth Factor 23 (FGF-23)
time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
description: Change from baseline in bone turnover markers including fibroblast growth factor 23 (FGF-23) was reported for combined Part 2 and 3. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Biochemical Bone Markers for Parathyroid Hormone (PTH)
time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
description: Change from baseline in bone turnover markers for parathyroid hormone was reported for combined Part 2 and 3. End of the study is the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Biochemical Bone Markers for Fetuin-A
time frame: Baseline, Week 8, Week 16 and EOS (up to 42 weeks)
description: Change from baseline in bone turnover markers for fetuin-A was reported for combined Part 2 and 3. End of the study is the completion if the participants has benefited from and desires to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Height
time frame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
description: Change from baseline in height for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
measure: Change From Baseline in Weight
time frame: Baseline, Week 8, Week 16, and EOS (up to 42 weeks)
description: Change from baseline in weight for combined Part 2 and Part 3 for each drug at Week 8, 16 and end of study was reported. End of the study was defined as the completion if the participants benefited from and desired to continue dosing with lanthanum. Here, number of participants analyzed refers to the number of participants evaluable for this outcome at specified time point. Data was analyzed and presented as per the intervention received in this study related to this outcome and not analyzed based on each part of the study.
arm group label: Lanthanum Carbonate
arm group type: Experimental
description: Participants will receive lanthanum carbonate orally at a total daily dose of 1500 mg to 3000 mg divided and mixed equally between in three meals.
arm group label: Calcium Carbonate
arm group type: Active Comparator
description: Participants will receive calcium carbonate orally at a total daily dose adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
intervention type: Drug
intervention name: Lanthanum Carbonate
description: Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
arm group label: Lanthanum Carbonate
other name: SPD405
intervention type: Drug
intervention name: Calcium Carbonate
description: Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
arm group label: Calcium Carbonate
criteria: 
gender: All
minimum age: 10 Years
maximum age: 17 Years
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
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country: Argentina
country: Chile
country: Czechia
country: Germany
country: Hungary
country: Poland
country: Romania
country: Russian Federation
country: Turkey
country: Bulgaria
country: Czech Republic
country: South Africa
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hyperphosphatemia
mesh term: Calcium Carbonate
mesh term: Calcium
provided document: 
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reported events: 
certain agreements: 
limitations and caveats: Data was analyzed and presented as per the intervention received in this study and not analyzed based on each part of the study. Lanthanum carbonate data was combined and analysed for Part 2 and 3 in the entire study and separately for Part 1.
point of contact: 