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Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia (LAVALIER)

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ClinicalTrials.gov Identifier: NCT02237534
Recruitment Status : Enrolling by invitation
First Posted : September 11, 2014
Last Update Posted : August 31, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Takayuki Hamano, Osaka University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Hyperphosphatemia Bone Diseases, Metabolic Drug: Lanthanum carbonate Drug: Calcium Carbonate Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia
Study Start Date : September 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Active Comparator: Calcium carbonate
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.
Drug: Calcium Carbonate
Experimental: Lanthanum carbonate
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.
Drug: Lanthanum carbonate
Other Name: FOSRENOL®




Primary Outcome Measures :
  1. Coronary artery calcification score [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Endothelial function [ Time Frame: 3 months ]
    Measured by EndoPAT™ (Itamar Medical Ltd.)

  2. Serum bone metabolic markers [ Time Frame: 3 months ]
    Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)

  3. Serum bone metabolic markers [ Time Frame: 1 year ]
    Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)

  4. Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time [ Time Frame: Up to 1 year ]
  5. Estimated glomerular filtration rate over time [ Time Frame: Up to 1 year ]
  6. Bone mineral density [ Time Frame: 1 year ]
  7. Serum osteoprotegerin concentration [ Time Frame: 3 month ]
  8. Serum osteoprotegerin concentration [ Time Frame: 1 year ]
  9. Urinary alpha-Klotho to creatinine ratio [ Time Frame: 3 months ]
  10. Urinary alpha-Klotho to creatinine ratio [ Time Frame: 1 year ]
  11. Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio [ Time Frame: 3 months ]
  12. Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio [ Time Frame: 1 year ]
  13. End-stage renal disease requiring renal replacement therapy [ Time Frame: Up to 1 year ]
  14. Cardiovascular event requiring hospitalization [ Time Frame: Up to 1 year ]
    Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease

  15. Death [ Time Frame: Up to 1 year ]

Other Outcome Measures:
  1. Micro RNA array [ Time Frame: 1 year ]
  2. Hypercalcemia [ Time Frame: Up to 1 year ]
    Corrected serum calcium concentration ≥11.0 mg/dL

  3. Hypocalcemia [ Time Frame: Up to 1 year ]
    Corrected serum calcium concentration <8.5 mg/dL



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL)
  • With written informed consent

Exclusion Criteria:

  • History of cardiac surgery
  • With coronary artery stent
  • Polycystic kidney disease
  • Hypothyroidism
  • On treatment with lanthanum carbonate
  • History of admission within 3 months
  • History of ileus
  • Severe liver dysfunction
  • Severe gastrointestinal dysfunction
  • Allergy to lanthanum carbonate or calcium carbonate
  • Pregnant or breastfeeding women
  • Judged as ineligible by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02237534


Locations
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Japan
Osaka University Hospital
Suita, Osaka, Japan, 565-0871
Sponsors and Collaborators
Osaka University
Bayer
Investigators
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Study Chair: Takayuki Hamano, MD, PhD Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine
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Responsible Party: Takayuki Hamano, Endowed chair, Osaka University
ClinicalTrials.gov Identifier: NCT02237534    
Other Study ID Numbers: CKDR-002
First Posted: September 11, 2014    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Keywords provided by Takayuki Hamano, Osaka University:
Lanthanum
Calcium Carbonate
Vascular Calcification
Additional relevant MeSH terms:
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Bone Diseases
Bone Diseases, Metabolic
Renal Insufficiency
Renal Insufficiency, Chronic
Hyperphosphatemia
Metabolic Diseases
Kidney Diseases
Urologic Diseases
Musculoskeletal Diseases
Phosphorus Metabolism Disorders
Calcium Carbonate
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents