<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/NCT03001011</url>
  </required_header>
  <id_info>
    <org_study_id>EFC14011</org_study_id>
    <secondary_id>U1111-1161-9850</secondary_id>
    <nct_id>NCT03001011</nct_id>
  </id_info>
  <brief_title>Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China</brief_title>
  <acronym>RECOVER</acronym>
  <official_title>A Randomized, Double Blind, Parallel Group Study For Assessing The Efficacy And Safety Of Renvela® Tablets For The Treatment Of Hyperphosphatemia In Patients With Chronic Kidney Disease Not On Dialysis Versus Placebo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sanofi</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sanofi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary Objective:&#xD;
&#xD;
      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in&#xD;
      hyperphosphatemia in participants with chronic kidney disease not on dialysis.&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To document the efficacy of Renvela tablets in the reduction of serum lipids (total&#xD;
      cholesterol and low-density lipoprotein cholesterol [LDL-C]).&#xD;
&#xD;
      To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.&#xD;
&#xD;
      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone&#xD;
      (iPTH).&#xD;
&#xD;
      To document the efficacy of Renvela tablets in proportion of participants reaching the target&#xD;
      serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre&#xD;
      [mmol/L], inclusive).&#xD;
&#xD;
      To evaluate safety of Renvela tablets.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The total duration of study period per participant was up to 14 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2017</start_date>
  <completion_date type="Actual">August 16, 2019</completion_date>
  <primary_completion_date type="Actual">August 16, 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Serum Phosphorus at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward [LOCF] method.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Total Cholesterol at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Missing Week 8 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Missing Week 8 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Calcium-Phosphorus Product at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Missing Week 8 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8</measure>
    <time_frame>Baseline, Week 8</time_frame>
    <description>Missing Week 8 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8</measure>
    <time_frame>Week 8</time_frame>
    <description>Missing Week 8 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Phosphorus Level at Week 4</measure>
    <time_frame>Baseline, Week 4</time_frame>
    <description>Missing Week 4 data were imputed by LOCF method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment Emergent Adverse Event</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant abnormalities:&#xD;
Hemoglobin: &lt;=115 g/L (Male[M]) or &lt;=95 g/L (Female [F]); &gt;=185 g/L (M) or &gt;=165 g/L (F); Decrease from baseline (DFB) &gt;=20 g/L&#xD;
Hematocrit: &lt;=0.37 v/v (M) or &lt;=0.32 v/v (F); &gt;=0.55 v/v (M) or &gt;=0.5 v/v (F)&#xD;
Red blood cells (RBC): &gt;=6 Tera/L&#xD;
Platelets: &lt;100 Giga/L; &gt;=700 Giga/L&#xD;
White blood cells (WBC): &lt;3.0 Giga/L (Non-Black [NB]) or &lt;2.0 Giga/L (Black [B]); &gt;=16.0 Giga/L&#xD;
Neutrophils: &lt;1.5 Giga/L (NB) or &lt;1.0 Giga/L (B); &lt;1.0 Giga/L&#xD;
Lymphocytes: &gt;4.0 Giga/L&#xD;
Monocytes: &gt;0.7 Giga/L&#xD;
Basophils: &gt;0.1 Giga/L&#xD;
Eosinophils: &gt;0.5 Giga/L or &gt;upper limit of normal (ULN) (if ULN &gt;=0.5 Giga/L)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant abnormalities:&#xD;
Glucose: &lt;=3.9 mmol/L and &lt; lower limits of normal (LLN); &gt;=11.1 mmol/L (unfasted [unfas]) or &gt;=7 mmol/L (fasted [fas])&#xD;
Triglycerides: &gt;=4.6 mmol/L&#xD;
Albumin: &lt;= 25 g/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant abnormalities:&#xD;
Sodium: &lt;=129 millimoles (mmol)/L; &gt;=160 mmol/L Potassium: &lt;3 mmol/L; &gt;=5.5 mmol/L Chloride: &lt;80 mmol/L; &gt;115 mmol/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant abnormalities:&#xD;
Creatinine: &gt;=150 micromol/L; &gt;=30% change from baseline, &gt;=100% change from baseline Creatinine clearance: &lt;15 mL/min; &gt;=15 to &lt;30 mL/min; &gt;=30 to &lt;60 mL/min; &gt;=60 to &lt;90 mL/min Blood urea nitrogen: &gt;=17 mmol/L Uric acid: &lt;120 micromol/L; &gt;408 micromol/L Glomular Filtration Rate (GFR): &lt; 15 mL/min/1.73m^2, &gt;= 15 - &lt; 30 mL/min/1.73m^2, &gt;= 30 - &lt; 60 mL/min/1.73m^2, &gt;= 60 - &lt; 90 mL/min/1.73m^2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant abnormalities:&#xD;
Alanine Aminotransferase (ALT): &gt;3 ULN; &gt;5 ULN; &gt;10 ULN; Aspartate aminotransferase (AST): &gt;3 ULN.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinically Significant Vital Signs Abnormalities</measure>
    <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
    <description>Criteria for potentially clinically significant vital sign abnormalities:&#xD;
Systolic blood pressure (SBP) supine: &lt;=95 millimeters of mercury (mmHg) and DFB &gt;=20 mmHg; &gt;=160 mmHg and increase from baseline (IFB) &gt;=20 mmHg Diastolic blood pressure (DBP) supine: &lt;=45 mmHg and DFB &gt;=10 mmHg; &gt;=110 mmHg and IFB &gt;=10 mmHg Heart rate (HR) supine: &lt;=50 beats per minute (bpm) and DFB &gt;=20 bpm; &gt;=120 bpm and IFB &gt;=20 bpm Weight: &gt;=5% DFB; &gt;=5% IFB.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">202</enrollment>
  <condition>Hyperphosphatemia</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (&lt;=) 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Renvela</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevelamer Carbonate (GZ419831)</intervention_name>
    <description>Pharmaceutical form: tablet&#xD;
Route of administration: oral</description>
    <arm_group_label>Renvela</arm_group_label>
    <other_name>Renvela</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Participants with chronic kidney disease who had not been on dialysis, and were not&#xD;
             expected to begin dialysis, or renal transplantation in the next 4 months from the&#xD;
             screening visit.&#xD;
&#xD;
          -  Had serum phosphorus measurement greater than or equal to (&gt;=) 5.5 mg/dL (1.78 mmol/L)&#xD;
             at screening visit (if participants were not on phosphate binder[s] at Screening&#xD;
             Visit) OR at the end of Washout Period (if participants were on phosphate binder[s] at&#xD;
             screening visit).&#xD;
&#xD;
          -  Had the following laboratory measurements at screening visit:&#xD;
&#xD;
               -  25-hydroxy vitamin D &gt;=10 nanograms per milliliter (ng/mL).&#xD;
&#xD;
               -  intact parathyroid hormone, intact parathyroid hormone (iPTH) &lt;=800 picograms per&#xD;
                  millilitre (pg/mL).&#xD;
&#xD;
               -  Signed written informed consent.&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Men or women below 18 years of age.&#xD;
&#xD;
          -  Any technical/administrative reason that made it impossible to randomize the&#xD;
             participant in the study.&#xD;
&#xD;
          -  Was not of the level of understanding and willingness to cooperate with all visits and&#xD;
             procedures, as described in the study protocol.&#xD;
&#xD;
          -  Not yet received chronic kidney disease diet education before screening visit.&#xD;
&#xD;
          -  Not willing and not able to avoid changes to diet during the study.&#xD;
&#xD;
          -  Not willing or able to maintain screening doses of lipid lowering medication, 1, 25&#xD;
             dihydroxy vitamin D, and/or cinacalcet for the duration of the study, except for&#xD;
             safety reasons.&#xD;
&#xD;
          -  Not willing or not able to avoid antacids and phosphate binders containing aluminium,&#xD;
             magnesium, calcium, or lanthanum for the duration of the study unless prescribed as an&#xD;
             evening calcium supplement.&#xD;
&#xD;
          -  Had participated in any other investigational drug studies within 30 days, or 5 half&#xD;
             lives, whichever is longer, prior to screening visit.&#xD;
&#xD;
          -  Conditions/situations such as:&#xD;
&#xD;
               -  Participant was the Investigator or any Subinvestigator, research assistant,&#xD;
                  pharmacist, study coordinator, other staff or relative thereof directly involved&#xD;
                  in the conduct of the protocol.&#xD;
&#xD;
               -  Uncooperative or any condition that could make the participant potentially&#xD;
                  non-compliant to the study procedures (for example, participants could not be&#xD;
                  contacted by phones as required in phone call visits).&#xD;
&#xD;
               -  Evidence of active malignancy.&#xD;
&#xD;
               -  Not on stable medical condition (for example, but not limited to, active ethanol&#xD;
                  or drug abuse [tobacco use acceptable]; documented poorly controlled diabetes&#xD;
                  mellitus, poorly controlled hypertension, active vasculitis, human&#xD;
                  immunodeficiency virus [HIV] infection), or had any clinically significant&#xD;
                  medical conditions.&#xD;
&#xD;
          -  Had known hypersensitivity to sevelamer or any constituents of Renvela tablets.&#xD;
&#xD;
          -  Had bowel obstruction, active dysphagia or swallowing disorder, or a predisposition to&#xD;
             or current bowel obstruction, ileus, or severe gastrointestinal motility disorders&#xD;
             including severe constipation.&#xD;
&#xD;
          -  Using or plan to use anti-arrhythmic or anti-seizure medications for arrhythmia or&#xD;
             seizure disorders.&#xD;
&#xD;
          -  Was pregnant or breast-feeding.&#xD;
&#xD;
          -  If the participant was female, and of childbearing potential (pre-menopausal and not&#xD;
             surgically sterile), was not willing to use an effective contraceptive method&#xD;
             throughout the study.&#xD;
&#xD;
          -  Had any condition, which in the opinion of the investigator would prohibit the&#xD;
             participant's inclusion in the study.&#xD;
&#xD;
        The above information was not intended to contain all considerations relevant to a&#xD;
        participant's potential participation in a clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Sciences &amp; Operations</last_name>
    <role>Study Director</role>
    <affiliation>Sanofi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Investigational Site Number 1560003</name>
      <address>
        <city>Beijing</city>
        <zip>100034</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560026</name>
      <address>
        <city>Cangzhou</city>
        <zip>061000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560015</name>
      <address>
        <city>Changchun</city>
        <zip>130021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560011</name>
      <address>
        <city>Changsha</city>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560030</name>
      <address>
        <city>Chongqing</city>
        <zip>400038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560019</name>
      <address>
        <city>Dalian</city>
        <zip>116011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560013</name>
      <address>
        <city>Fuzhou</city>
        <zip>350005</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560001</name>
      <address>
        <city>Guangzhou</city>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560027</name>
      <address>
        <city>Guangzhou</city>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560037</name>
      <address>
        <city>Guilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560031</name>
      <address>
        <city>Haikou</city>
        <zip>570311</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560036</name>
      <address>
        <city>Hengyang</city>
        <zip>421001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560039</name>
      <address>
        <city>Hengyang</city>
        <zip>421001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560023</name>
      <address>
        <city>Hohhot</city>
        <zip>010050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560033</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560034</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560006</name>
      <address>
        <city>Lanzhou</city>
        <zip>730030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560004</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560005</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560032</name>
      <address>
        <city>Nanchang</city>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560017</name>
      <address>
        <city>Nanjing</city>
        <zip>210011</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560029</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560028</name>
      <address>
        <city>Ningbo</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560002</name>
      <address>
        <city>Shanghai</city>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560007</name>
      <address>
        <city>Shanghai</city>
        <zip>200072</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560021</name>
      <address>
        <city>Shenyang</city>
        <zip>110004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560038</name>
      <address>
        <city>Shenyang</city>
        <zip>110016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560025</name>
      <address>
        <city>Shijiazhuang</city>
        <zip>050000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560022</name>
      <address>
        <city>Taiyuan</city>
        <zip>030001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560012</name>
      <address>
        <city>Tianjin</city>
        <zip>300052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560014</name>
      <address>
        <city>Tianjin</city>
        <zip>300121</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560010</name>
      <address>
        <city>Wuhan</city>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560008</name>
      <address>
        <city>Xi'An</city>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560020</name>
      <address>
        <city>Xiamen</city>
        <zip>361003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560018</name>
      <address>
        <city>Xiamen</city>
        <zip>361004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560035</name>
      <address>
        <city>Xuzhou</city>
        <zip>221002</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560024</name>
      <address>
        <city>Yinchuan</city>
        <zip>750004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Site Number 1560016</name>
      <address>
        <city>Zhanjiang</city>
        <zip>524001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>July 9, 2020</results_first_submitted>
  <results_first_submitted_qc>July 9, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">July 28, 2020</results_first_posted>
  <last_update_submitted>March 15, 2022</last_update_submitted>
  <last_update_submitted_qc>March 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</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>Sevelamer</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org</ipd_description>
  </patient_data>
  <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>April 13, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03001011/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>September 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/11/NCT03001011/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Study was conducted at 38 centers in China. A total of 482 participants were screened between 07 June 2017 &amp; 30 May 2019, of which 280 participants were screen failures. Screen failures were mainly due to serum phosphorus level greater than or equal to &gt;=5.5 milligrams per deciliter (mg/dL) (1.78 millimoles per litre [mmol/L]) at screening visit.</recruitment_details>
      <pre_assignment_details>A total of 202 participants were randomized in the study. Randomization was stratified according to screening serum phosphorus level (&gt;=5.5 - 6.0 mg/dL [1.78 - 1.94 mmol/L] and &gt;6.0 mg/dL [1.94 mmol/L]). Assignment to arms was done centrally using interactive voice/web response system in 1:1 ratio (Renvela [sevelamer carbonate]: placebo).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Placebo</title>
          <description>Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (&lt;=) 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
        <group group_id="P2">
          <title>Renvela</title>
          <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="74"/>
                <participants group_id="P2" count="80"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Chronic kidney disease lead to dialysis</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other than specified above</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed on randomized participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
        <group group_id="B2">
          <title>Renvela</title>
          <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
            <count group_id="B2" value="101"/>
            <count group_id="B3" value="202"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.9" spread="12.4"/>
                    <measurement group_id="B2" value="50.6" spread="13.5"/>
                    <measurement group_id="B3" value="50.7" spread="12.9"/>
                  </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="46"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="101"/>
                    <measurement group_id="B3" value="202"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Serum Phosphorus at Week 8</title>
        <description>Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward [LOCF] method.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Modified intention to treat (mITT) population: all participants who were randomized, received at least 1 dose of IMP &amp; had both baseline assessment &amp; at least 1 post-baseline assessment of phosphorus measure. Here, number analyzed = participants with available data at specified time points.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphorus at Week 8</title>
          <description>Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward [LOCF] method.</description>
          <population>Modified intention to treat (mITT) population: all participants who were randomized, received at least 1 dose of IMP &amp; had both baseline assessment &amp; at least 1 post-baseline assessment of phosphorus measure. Here, number analyzed = participants with available data at specified time points.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
                <count group_id="O2" value="98"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="93"/>
                    <count group_id="O2" value="98"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.090" lower_limit="1.870" upper_limit="2.270"/>
                    <measurement group_id="O2" value="2.095" lower_limit="1.870" upper_limit="2.400"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Change at Week 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.010" lower_limit="-0.200" upper_limit="0.250"/>
                    <measurement group_id="O2" value="-0.200" lower_limit="-0.490" upper_limit="0.020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A hierarchical testing procedure was used to control type I error &amp; handle multiple secondary endpoint analyses. Testing was then performed sequentially in order outcome measures (OM) are reported. The hierarchical testing sequence continued only when previous OM was statistically significant at 0.05 level.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <p_value_desc>Threshold for statistical significance at 0.05.</p_value_desc>
            <method>Wilcoxon rank sum test</method>
            <param_type>Median difference (Renvela - Placebo)</param_type>
            <param_value>-0.210</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Renvela Vs. Placebo</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Total Cholesterol at Week 8</title>
        <description>Missing Week 8 data were imputed by LOCF method.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Total Cholesterol at Week 8</title>
          <description>Missing Week 8 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="82"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.115" lower_limit="-1.82" upper_limit="1.54"/>
                    <measurement group_id="O2" value="-0.830" lower_limit="-4.45" upper_limit="0.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8</title>
        <description>Missing Week 8 data were imputed by LOCF method.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8</title>
          <description>Missing Week 8 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="81"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.030" lower_limit="-1.61" upper_limit="1.30"/>
                    <measurement group_id="O2" value="-0.830" lower_limit="-3.31" upper_limit="0.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Calcium-Phosphorus Product at Week 8</title>
        <description>Missing Week 8 data were imputed by LOCF method.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Calcium-Phosphorus Product at Week 8</title>
          <description>Missing Week 8 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>mmol^2/L^2</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0200" lower_limit="-2.648" upper_limit="2.936"/>
                    <measurement group_id="O2" value="-0.4960" lower_limit="-2.592" upper_limit="2.696"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8</title>
        <description>Missing Week 8 data were imputed by LOCF method.</description>
        <time_frame>Baseline, Week 8</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8</title>
          <description>Missing Week 8 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>nanogram per liter (ng/L)</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.2380" lower_limit="-298.732" upper_limit="573.306"/>
                    <measurement group_id="O2" value="0.0000" lower_limit="-370.172" upper_limit="327.966"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8</title>
        <description>Missing Week 8 data were imputed by LOCF method.</description>
        <time_frame>Week 8</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8</title>
          <description>Missing Week 8 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</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="91"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6"/>
                    <measurement group_id="O2" value="15.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Phosphorus Level at Week 4</title>
        <description>Missing Week 4 data were imputed by LOCF method.</description>
        <time_frame>Baseline, Week 4</time_frame>
        <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Phosphorus Level at Week 4</title>
          <description>Missing Week 4 data were imputed by LOCF method.</description>
          <population>Analysis was performed on mITT population. Here, overall number of participants analyzed = participants with available data for this outcome measure.</population>
          <units>mmol/L</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="91"/>
                <count group_id="O2" value="97"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.020" lower_limit="-1.56" upper_limit="2.42"/>
                    <measurement group_id="O2" value="-0.240" lower_limit="-1.03" upper_limit="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment Emergent Adverse Event</title>
        <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population that consisted of all randomized participants who received at least one dose of IMP.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment Emergent Adverse Event</title>
          <description>Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.</description>
          <population>Analysis was performed on safety population that consisted of all randomized participants who received at least one dose of IMP.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any TEAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Any Treatment emergent SAE</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>any TEAE leading to permanent discontinuation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters</title>
        <description>Criteria for potentially clinically significant abnormalities:&#xD;
Hemoglobin: &lt;=115 g/L (Male[M]) or &lt;=95 g/L (Female [F]); &gt;=185 g/L (M) or &gt;=165 g/L (F); Decrease from baseline (DFB) &gt;=20 g/L&#xD;
Hematocrit: &lt;=0.37 v/v (M) or &lt;=0.32 v/v (F); &gt;=0.55 v/v (M) or &gt;=0.5 v/v (F)&#xD;
Red blood cells (RBC): &gt;=6 Tera/L&#xD;
Platelets: &lt;100 Giga/L; &gt;=700 Giga/L&#xD;
White blood cells (WBC): &lt;3.0 Giga/L (Non-Black [NB]) or &lt;2.0 Giga/L (Black [B]); &gt;=16.0 Giga/L&#xD;
Neutrophils: &lt;1.5 Giga/L (NB) or &lt;1.0 Giga/L (B); &lt;1.0 Giga/L&#xD;
Lymphocytes: &gt;4.0 Giga/L&#xD;
Monocytes: &gt;0.7 Giga/L&#xD;
Basophils: &gt;0.1 Giga/L&#xD;
Eosinophils: &gt;0.5 Giga/L or &gt;upper limit of normal (ULN) (if ULN &gt;=0.5 Giga/L)</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for the specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL [&lt;=1.49 mmol/L]).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters</title>
          <description>Criteria for potentially clinically significant abnormalities:&#xD;
Hemoglobin: &lt;=115 g/L (Male[M]) or &lt;=95 g/L (Female [F]); &gt;=185 g/L (M) or &gt;=165 g/L (F); Decrease from baseline (DFB) &gt;=20 g/L&#xD;
Hematocrit: &lt;=0.37 v/v (M) or &lt;=0.32 v/v (F); &gt;=0.55 v/v (M) or &gt;=0.5 v/v (F)&#xD;
Red blood cells (RBC): &gt;=6 Tera/L&#xD;
Platelets: &lt;100 Giga/L; &gt;=700 Giga/L&#xD;
White blood cells (WBC): &lt;3.0 Giga/L (Non-Black [NB]) or &lt;2.0 Giga/L (Black [B]); &gt;=16.0 Giga/L&#xD;
Neutrophils: &lt;1.5 Giga/L (NB) or &lt;1.0 Giga/L (B); &lt;1.0 Giga/L&#xD;
Lymphocytes: &gt;4.0 Giga/L&#xD;
Monocytes: &gt;0.7 Giga/L&#xD;
Basophils: &gt;0.1 Giga/L&#xD;
Eosinophils: &gt;0.5 Giga/L or &gt;upper limit of normal (ULN) (if ULN &gt;=0.5 Giga/L)</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for the specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hemoglobin &lt;=115 g/L (M) or &lt;=95 g/L (F)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin &gt;=185 g/L (M) or &gt;=165 g/L (F)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoglobin DFB &gt;=20 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit &lt;=0.37 v/v (M) or &lt;=0.32 v/v (F)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit &gt;0.55 v/v (M) or &gt;=0.5 v/v (F)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>RBC &gt;=6 Tera/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &lt;100 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelets &gt;=700 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="83"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC &lt;3.0 Giga/L (NB) or &lt;2.0 Giga/L (B)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>WBC &gt;=16.0 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils &lt;1.5 Giga/L (NB) or &lt;1.0 Giga/L (B)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes &gt;4 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes &gt;0.7 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils &gt;0.1 Giga/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils &gt;0.5 Giga/L or &gt;ULN (ULN &gt;=0.5 Giga/L)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="75"/>
                    <count group_id="O2" value="82"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters</title>
        <description>Criteria for potentially clinically significant abnormalities:&#xD;
Glucose: &lt;=3.9 mmol/L and &lt; lower limits of normal (LLN); &gt;=11.1 mmol/L (unfasted [unfas]) or &gt;=7 mmol/L (fasted [fas])&#xD;
Triglycerides: &gt;=4.6 mmol/L&#xD;
Albumin: &lt;= 25 g/L.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters</title>
          <description>Criteria for potentially clinically significant abnormalities:&#xD;
Glucose: &lt;=3.9 mmol/L and &lt; lower limits of normal (LLN); &gt;=11.1 mmol/L (unfasted [unfas]) or &gt;=7 mmol/L (fasted [fas])&#xD;
Triglycerides: &gt;=4.6 mmol/L&#xD;
Albumin: &lt;= 25 g/L.</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Triglycerides: &gt;=4.6 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="78"/>
                    <count group_id="O2" value="84"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: =&lt; 3.9 mmol/L and &lt; LLN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose: &gt;=11.1 mmol/L(unfas); &gt;=7 mmol/L(fas)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin: &lt;= 25 g/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="91"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes</title>
        <description>Criteria for potentially clinically significant abnormalities:&#xD;
Sodium: &lt;=129 millimoles (mmol)/L; &gt;=160 mmol/L Potassium: &lt;3 mmol/L; &gt;=5.5 mmol/L Chloride: &lt;80 mmol/L; &gt;115 mmol/L.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes</title>
          <description>Criteria for potentially clinically significant abnormalities:&#xD;
Sodium: &lt;=129 millimoles (mmol)/L; &gt;=160 mmol/L Potassium: &lt;3 mmol/L; &gt;=5.5 mmol/L Chloride: &lt;80 mmol/L; &gt;115 mmol/L.</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sodium &lt;=129 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium &gt;=160 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &lt;3 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium &gt;=5.5 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="93"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride &lt;80 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride &gt;115 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters</title>
        <description>Criteria for potentially clinically significant abnormalities:&#xD;
Creatinine: &gt;=150 micromol/L; &gt;=30% change from baseline, &gt;=100% change from baseline Creatinine clearance: &lt;15 mL/min; &gt;=15 to &lt;30 mL/min; &gt;=30 to &lt;60 mL/min; &gt;=60 to &lt;90 mL/min Blood urea nitrogen: &gt;=17 mmol/L Uric acid: &lt;120 micromol/L; &gt;408 micromol/L Glomular Filtration Rate (GFR): &lt; 15 mL/min/1.73m^2, &gt;= 15 - &lt; 30 mL/min/1.73m^2, &gt;= 30 - &lt; 60 mL/min/1.73m^2, &gt;= 60 - &lt; 90 mL/min/1.73m^2.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters</title>
          <description>Criteria for potentially clinically significant abnormalities:&#xD;
Creatinine: &gt;=150 micromol/L; &gt;=30% change from baseline, &gt;=100% change from baseline Creatinine clearance: &lt;15 mL/min; &gt;=15 to &lt;30 mL/min; &gt;=30 to &lt;60 mL/min; &gt;=60 to &lt;90 mL/min Blood urea nitrogen: &gt;=17 mmol/L Uric acid: &lt;120 micromol/L; &gt;408 micromol/L Glomular Filtration Rate (GFR): &lt; 15 mL/min/1.73m^2, &gt;= 15 - &lt; 30 mL/min/1.73m^2, &gt;= 30 - &lt; 60 mL/min/1.73m^2, &gt;= 60 - &lt; 90 mL/min/1.73m^2.</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Creatinine &gt;=150 micromol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine &gt;=30% change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine &gt;=100% change from baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine Clearance &lt;15 mL/min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine clearance &gt;=15 to &lt;30 mL/min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine clearance &gt;=30 to &lt;60 mL/min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine clearance &gt;=60 to &lt;90 mL/min</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen &gt;=17 mmol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="79"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric acid &lt;120 micromol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric acid &gt;408 micromol/L</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="86"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="56"/>
                    <measurement group_id="O2" value="67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR &lt; 15 mL/min/1.73m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR &gt;= 15 - &lt; 30 mL/min/1.73m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR &gt;= 30 - &lt; 60 mL/min/1.73m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>GFR &gt;= 60 - &lt; 90 mL/min/1.73m^2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="84"/>
                    <count group_id="O2" value="89"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters</title>
        <description>Criteria for potentially clinically significant abnormalities:&#xD;
Alanine Aminotransferase (ALT): &gt;3 ULN; &gt;5 ULN; &gt;10 ULN; Aspartate aminotransferase (AST): &gt;3 ULN.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters</title>
          <description>Criteria for potentially clinically significant abnormalities:&#xD;
Alanine Aminotransferase (ALT): &gt;3 ULN; &gt;5 ULN; &gt;10 ULN; Aspartate aminotransferase (AST): &gt;3 ULN.</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALT &gt;3 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT &gt;5 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT &gt;10 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="77"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST &gt;3 ULN</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="76"/>
                    <count group_id="O2" value="85"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
        <description>Criteria for potentially clinically significant vital sign abnormalities:&#xD;
Systolic blood pressure (SBP) supine: &lt;=95 millimeters of mercury (mmHg) and DFB &gt;=20 mmHg; &gt;=160 mmHg and increase from baseline (IFB) &gt;=20 mmHg Diastolic blood pressure (DBP) supine: &lt;=45 mmHg and DFB &gt;=10 mmHg; &gt;=110 mmHg and IFB &gt;=10 mmHg Heart rate (HR) supine: &lt;=50 beats per minute (bpm) and DFB &gt;=20 bpm; &gt;=120 bpm and IFB &gt;=20 bpm Weight: &gt;=5% DFB; &gt;=5% IFB.</description>
        <time_frame>From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59</time_frame>
        <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Participants received placebo (for Renvela) orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;= 4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
          <group group_id="O2">
            <title>Renvela</title>
            <description>Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinically Significant Vital Signs Abnormalities</title>
          <description>Criteria for potentially clinically significant vital sign abnormalities:&#xD;
Systolic blood pressure (SBP) supine: &lt;=95 millimeters of mercury (mmHg) and DFB &gt;=20 mmHg; &gt;=160 mmHg and increase from baseline (IFB) &gt;=20 mmHg Diastolic blood pressure (DBP) supine: &lt;=45 mmHg and DFB &gt;=10 mmHg; &gt;=110 mmHg and IFB &gt;=10 mmHg Heart rate (HR) supine: &lt;=50 beats per minute (bpm) and DFB &gt;=20 bpm; &gt;=120 bpm and IFB &gt;=20 bpm Weight: &gt;=5% DFB; &gt;=5% IFB.</description>
          <population>Analysis was performed on safety population. Here, number analyzed = participants with available data for specified categories.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>SBP (supine) &lt;=95 mmHg and DFB &gt;=20 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>SBP (supine) &gt;=160 mmHg and IFB &gt;=20 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP (supine) &lt;=45 mmHg and DFB &gt;=10 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>DBP (supine) &gt;=110 mmHg and IFB &gt;=10 mmHg</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HR (supine) &lt;=50 bpm and DFB &gt;= 20 bpm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>HR (supine) &gt;=120 bpm and IFB &gt;=20 bpm</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight &gt;=5% DFB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Weight &gt;=5% IFB</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="92"/>
                    <count group_id="O2" value="97"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Reported AEs are TEAEs that is AEs that developed/worsened or became serious during the TEAE period (time from the first dose of IMP to the last dose of IMP+3 days i.e. Day 59).</time_frame>
      <desc>Analysis was performed on safety population.</desc>
      <group_list>
        <group group_id="E1">
          <title>Placebo</title>
          <description>Participants received placebo (for Renvela) orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
        <group group_id="E2">
          <title>Renvela</title>
          <description>Participants received Renvela orally TID with meals up to 8 weeks as directed by physician and were titrated to reach a target goal of serum phosphorus &lt;=4.6 mg/dL (&lt;=1.49 mmol/L).</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>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="101"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="31" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cardiac Failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cardiac Failure Acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Cataract</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Inguinal Hernia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Cholecystitis Acute</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Cholelithiasis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Lung Infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Pulmonary Tuberculosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Urinary Tract Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Femur Fracture</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="101"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Intervertebral Disc Protrusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Myofascitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral Haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute Kidney Injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Azotaemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Chronic Kidney Disease</sub_title>
                <counts group_id="E1" events="14" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diabetic Nephropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>End Stage Renal Disease</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="101"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Glomerulonephritis Chronic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Renal Impairment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Psoriasis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Arteriovenous Fistula Operation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="101"/>
              </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="101"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 22.0</default_vocab>
        <default_assessment>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="52" subjects_at_risk="101"/>
                <counts group_id="E2" subjects_affected="60" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal Distension</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="101"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="10" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="101"/>
                <counts group_id="E2" events="11" subjects_affected="10" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="17" subjects_affected="13" subjects_at_risk="101"/>
                <counts group_id="E2" events="20" subjects_affected="12" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Oedema Peripheral</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="101"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper Respiratory Tract Infection</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="101"/>
                <counts group_id="E2" events="8" subjects_affected="8" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased Appetite</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="101"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hyperkalaemia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="18" subjects_at_risk="101"/>
                <counts group_id="E2" events="31" subjects_affected="25" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="101"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Metabolic Acidosis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="101"/>
                <counts group_id="E2" events="5" subjects_affected="4" subjects_at_risk="101"/>
              </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>The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Trial Transparency Team</name_or_title>
      <organization>Sanofi aventis recherche &amp; développement</organization>
      <phone>800-633-1610 ext 1#</phone>
      <email>Contact-US@sanofi.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/NCT03001011
org study id: EFC14011
secondary id: U1111-1161-9850
nct id: NCT03001011
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Primary Objective:

      To demonstrate efficacy of Renvela tablets in the reduction of serum phosphorus in
      hyperphosphatemia in participants with chronic kidney disease not on dialysis.

      Secondary Objectives:

      To document the efficacy of Renvela tablets in the reduction of serum lipids (total
      cholesterol and low-density lipoprotein cholesterol [LDL-C]).

      To document the efficacy of Renvela tablets in the reduction of calcium-phosphorus product.

      To document the efficacy of Renvela tablets in the reduction of intact parathyroid hormone
      (iPTH).

      To document the efficacy of Renvela tablets in proportion of participants reaching the target
      serum phosphorus level 4.6 milligrams per decilitre (mg/dL) (1.47 millimoles per litre
      [mmol/L], inclusive).

      To evaluate safety of Renvela tablets.
The total duration of study period per participant was up to 14 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change From Baseline in Serum Phosphorus at Week 8
time frame: Baseline, Week 8
description: Baseline of serum phosphorus value was the last serum phosphorus level obtained before the first double-blind investigational medicinal product (IMP) dosing. Missing Week 8 data were imputed by last observation carried forward [LOCF] method.
measure: Change From Baseline in Total Cholesterol at Week 8
time frame: Baseline, Week 8
description: Missing Week 8 data were imputed by LOCF method.
measure: Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8
time frame: Baseline, Week 8
description: Missing Week 8 data were imputed by LOCF method.
measure: Change From Baseline in Calcium-Phosphorus Product at Week 8
time frame: Baseline, Week 8
description: Missing Week 8 data were imputed by LOCF method.
measure: Change From Baseline in Intact Parathyroid Hormone (Ipth) Level at Week 8
time frame: Baseline, Week 8
description: Missing Week 8 data were imputed by LOCF method.
measure: Percentage of Participants Reaching the Target Serum Phosphorus Level (4.6 mg/dL [1.49 mmol/L]) at Week 8
time frame: Week 8
description: Missing Week 8 data were imputed by LOCF method.
measure: Change From Baseline in Serum Phosphorus Level at Week 4
time frame: Baseline, Week 4
description: Missing Week 4 data were imputed by LOCF method.
measure: Number of Participants With Treatment Emergent Adverse Event
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an Adverse Event (AE) without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during TEAE period. On-treatment period was defined as the (time from the first dose of IMP to the last dose of IMP+3 days). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Hematological Parameters
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant abnormalities:
Hemoglobin: <=115 g/L (Male[M]) or <=95 g/L (Female [F]); >=185 g/L (M) or >=165 g/L (F); Decrease from baseline (DFB) >=20 g/L
Hematocrit: <=0.37 v/v (M) or <=0.32 v/v (F); >=0.55 v/v (M) or >=0.5 v/v (F)
Red blood cells (RBC): >=6 Tera/L
Platelets: <100 Giga/L; >=700 Giga/L
White blood cells (WBC): <3.0 Giga/L (Non-Black [NB]) or <2.0 Giga/L (Black [B]); >=16.0 Giga/L
Neutrophils: <1.5 Giga/L (NB) or <1.0 Giga/L (B); <1.0 Giga/L
Lymphocytes: >4.0 Giga/L
Monocytes: >0.7 Giga/L
Basophils: >0.1 Giga/L
Eosinophils: >0.5 Giga/L or >upper limit of normal (ULN) (if ULN >=0.5 Giga/L)
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Metabolic Parameters
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant abnormalities:
Glucose: <=3.9 mmol/L and < lower limits of normal (LLN); >=11.1 mmol/L (unfasted [unfas]) or >=7 mmol/L (fasted [fas])
Triglycerides: >=4.6 mmol/L
Albumin: <= 25 g/L.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Electrolytes
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant abnormalities:
Sodium: <=129 millimoles (mmol)/L; >=160 mmol/L Potassium: <3 mmol/L; >=5.5 mmol/L Chloride: <80 mmol/L; >115 mmol/L.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Renal Function Parameters
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant abnormalities:
Creatinine: >=150 micromol/L; >=30% change from baseline, >=100% change from baseline Creatinine clearance: <15 mL/min; >=15 to <30 mL/min; >=30 to <60 mL/min; >=60 to <90 mL/min Blood urea nitrogen: >=17 mmol/L Uric acid: <120 micromol/L; >408 micromol/L Glomular Filtration Rate (GFR): < 15 mL/min/1.73m^2, >= 15 - < 30 mL/min/1.73m^2, >= 30 - < 60 mL/min/1.73m^2, >= 60 - < 90 mL/min/1.73m^2.
measure: Number of Participants With Clinically Significant Laboratory Abnormalities: Liver Function Parameters
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant abnormalities:
Alanine Aminotransferase (ALT): >3 ULN; >5 ULN; >10 ULN; Aspartate aminotransferase (AST): >3 ULN.
measure: Number of Participants With Clinically Significant Vital Signs Abnormalities
time frame: From first dose of IMP to the last dose of IMP +3 days i.e. up to Day 59
description: Criteria for potentially clinically significant vital sign abnormalities:
Systolic blood pressure (SBP) supine: <=95 millimeters of mercury (mmHg) and DFB >=20 mmHg; >=160 mmHg and increase from baseline (IFB) >=20 mmHg Diastolic blood pressure (DBP) supine: <=45 mmHg and DFB >=10 mmHg; >=110 mmHg and IFB >=10 mmHg Heart rate (HR) supine: <=50 beats per minute (bpm) and DFB >=20 bpm; >=120 bpm and IFB >=20 bpm Weight: >=5% DFB; >=5% IFB.
arm group label: Placebo
arm group type: Placebo Comparator
description: Participants received placebo (for Renvela) orally 3 times per day (TID) for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus less than or equal to (<=) 4.6 mg/dL (<=1.49 mmol/L).
arm group label: Renvela
arm group type: Experimental
description: Participants received Renvela orally TID for up to 8 weeks. One to five tablets were taken with meals, as directed by physician and were titrated (up to a maximum of 15 tablets per day) to reach a target goal of serum phosphorus <=4.6 mg/dL (<=1.49 mmol/L).
intervention type: Drug
intervention name: Placebo
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Placebo
intervention type: Drug
intervention name: Sevelamer Carbonate (GZ419831)
description: Pharmaceutical form: tablet
Route of administration: oral
arm group label: Renvela
other name: Renvela
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Sciences & Operations
role: Study Director
affiliation: Sanofi
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country: China
responsible party type: Sponsor
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
mesh term: Hyperphosphatemia
mesh term: Sevelamer
sharing ipd: Yes
ipd description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
provided document: 
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participant flow: 
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outcome list: 
reported events: 
certain agreements: 
point of contact: 