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

Study Overview
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Brief Summary
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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.

Official Title
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Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia

Conditions
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Renal Insufficiency, Chronic, Hyperphosphatemia, Bone Diseases, Metabolic

Intervention / Treatment
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* Drug: Lanthanum carbonate
* Drug: Calcium Carbonate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium carbonate<br>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<br> <br> |
| Experimental: Lanthanum carbonate<br>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<br> <br> * Other names: FOSRENOL®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary artery calcification score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Measured by EndoPAT™ (Itamar Medical Ltd.) | 3 months | 
| Serum bone metabolic markers | Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b) | 3 months | 
| Serum bone metabolic markers | Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b) | 1 year | 
| Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time |  | Up to 1 year | 
| Estimated glomerular filtration rate over time |  | Up to 1 year | 
| Bone mineral density |  | 1 year | 
| Serum osteoprotegerin concentration |  | 3 month | 
| Serum osteoprotegerin concentration |  | 1 year | 
| Urinary alpha-Klotho to creatinine ratio |  | 3 months | 
| Urinary alpha-Klotho to creatinine ratio |  | 1 year | 
| Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio |  | 3 months | 
| Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio |  | 1 year | 
| End-stage renal disease requiring renal replacement therapy |  | Up to 1 year | 
| Cardiovascular event requiring hospitalization | Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease | Up to 1 year | 
| Death |  | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lanthanum, Calcium Carbonate, Vascular Calcification