<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/NCT02237534</url>
  </required_header>
  <id_info>
    <org_study_id>CKDR-002</org_study_id>
    <nct_id>NCT02237534</nct_id>
  </id_info>
  <brief_title>Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia</brief_title>
  <acronym>LAVALIER</acronym>
  <official_title>Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osaka University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Osaka University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the effect of lanthanum carbonate and calcium&#xD;
      carbonate on the progression of coronary calcification and vascular endothelial dysfunction.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2023</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2023</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Coronary artery calcification score</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Endothelial function</measure>
    <time_frame>3 months</time_frame>
    <description>Measured by EndoPAT™ (Itamar Medical Ltd.)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum bone metabolic markers</measure>
    <time_frame>3 months</time_frame>
    <description>Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum bone metabolic markers</measure>
    <time_frame>1 year</time_frame>
    <description>Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated glomerular filtration rate over time</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bone mineral density</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum osteoprotegerin concentration</measure>
    <time_frame>3 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum osteoprotegerin concentration</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary alpha-Klotho to creatinine ratio</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary alpha-Klotho to creatinine ratio</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>End-stage renal disease requiring renal replacement therapy</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiovascular event requiring hospitalization</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Up to 1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Micro RNA array</measure>
    <time_frame>1 year</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hypercalcemia</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Corrected serum calcium concentration ≥11.0 mg/dL</description>
  </other_outcome>
  <other_outcome>
    <measure>Hypocalcemia</measure>
    <time_frame>Up to 1 year</time_frame>
    <description>Corrected serum calcium concentration &lt;8.5 mg/dL</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Renal Insufficiency, Chronic</condition>
  <condition>Hyperphosphatemia</condition>
  <condition>Bone Diseases, Metabolic</condition>
  <arm_group>
    <arm_group_label>Calcium carbonate</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration &lt;4.5 mg/dL. Maximum dose is 3,000 mg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Lanthanum carbonate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration &lt;4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lanthanum carbonate</intervention_name>
    <arm_group_label>Lanthanum carbonate</arm_group_label>
    <other_name>FOSRENOL®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Carbonate</intervention_name>
    <arm_group_label>Calcium carbonate</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients&#xD;
             with calcium carbonate, ≥4.0 mg/dL)&#xD;
&#xD;
          -  With written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiac surgery&#xD;
&#xD;
          -  With coronary artery stent&#xD;
&#xD;
          -  Polycystic kidney disease&#xD;
&#xD;
          -  Hypothyroidism&#xD;
&#xD;
          -  On treatment with lanthanum carbonate&#xD;
&#xD;
          -  History of admission within 3 months&#xD;
&#xD;
          -  History of ileus&#xD;
&#xD;
          -  Severe liver dysfunction&#xD;
&#xD;
          -  Severe gastrointestinal dysfunction&#xD;
&#xD;
          -  Allergy to lanthanum carbonate or calcium carbonate&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Judged as ineligible by the investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Takayuki Hamano, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Osaka University Hospital</name>
      <address>
        <city>Suita</city>
        <state>Osaka</state>
        <zip>565-0871</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2014</study_first_posted>
  <last_update_submitted>February 24, 2021</last_update_submitted>
  <last_update_submitted_qc>February 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Osaka University</investigator_affiliation>
    <investigator_full_name>Takayuki Hamano</investigator_full_name>
    <investigator_title>Endowed chair</investigator_title>
  </responsible_party>
  <keyword>Lanthanum</keyword>
  <keyword>Calcium Carbonate</keyword>
  <keyword>Vascular Calcification</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bone Diseases</mesh_term>
    <mesh_term>Bone Diseases, Metabolic</mesh_term>
    <mesh_term>Renal Insufficiency</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
    <mesh_term>Hyperphosphatemia</mesh_term>
    <mesh_term>Metabolic Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium Carbonate</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02237534
org study id: CKDR-002
nct id: NCT02237534
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to compare the effect of lanthanum carbonate and calcium
      carbonate on the progression of coronary calcification and vascular endothelial dysfunction.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Coronary artery calcification score
time frame: 1 year
measure: Endothelial function
time frame: 3 months
description: Measured by EndoPAT™ (Itamar Medical Ltd.)
measure: Serum bone metabolic markers
time frame: 3 months
description: Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
measure: Serum bone metabolic markers
time frame: 1 year
description: Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
measure: Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
time frame: Up to 1 year
measure: Estimated glomerular filtration rate over time
time frame: Up to 1 year
measure: Bone mineral density
time frame: 1 year
measure: Serum osteoprotegerin concentration
time frame: 3 month
measure: Serum osteoprotegerin concentration
time frame: 1 year
measure: Urinary alpha-Klotho to creatinine ratio
time frame: 3 months
measure: Urinary alpha-Klotho to creatinine ratio
time frame: 1 year
measure: Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
time frame: 3 months
measure: Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
time frame: 1 year
measure: End-stage renal disease requiring renal replacement therapy
time frame: Up to 1 year
measure: Cardiovascular event requiring hospitalization
time frame: Up to 1 year
description: Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
measure: Death
time frame: Up to 1 year
measure: Micro RNA array
time frame: 1 year
measure: Hypercalcemia
time frame: Up to 1 year
description: Corrected serum calcium concentration ≥11.0 mg/dL
measure: Hypocalcemia
time frame: Up to 1 year
description: Corrected serum calcium concentration <8.5 mg/dL
arm group label: Calcium carbonate
arm group type: Active Comparator
description: Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day.
arm group label: Lanthanum carbonate
arm group type: Experimental
description: Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.
intervention type: Drug
intervention name: Lanthanum carbonate
arm group label: Lanthanum carbonate
other name: FOSRENOL®
intervention type: Drug
intervention name: Calcium Carbonate
arm group label: Calcium carbonate
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Takayuki Hamano, MD, PhD
role: Study Chair
affiliation: Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Osaka University
investigator full name: Takayuki Hamano
investigator title: Endowed chair
mesh term: Bone Diseases
mesh term: Bone Diseases, Metabolic
mesh term: Renal Insufficiency
mesh term: Renal Insufficiency, Chronic
mesh term: Hyperphosphatemia
mesh term: Metabolic Diseases
mesh term: Calcium Carbonate
mesh term: Calcium