Effects of Phosphate Binding With Sevelamer in Stage 3 Chronic Kidney Disease

Study Overview
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Brief Summary
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The purpose of this study is to determine whether lowering phosphate in patients with early chronic kidney disease with the phosphate binder sevelamer has beneficial effects on cardiovascular structure and function.

Official Title
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Does Phosphate Binding With Sevelamer Carbonate Improve Cardiovascular Structure and Function in Patients With Early Chronic Kidney Disease?

Conditions
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Kidney Failure, Chronic, Cardiovascular Diseases

Intervention / Treatment
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* Drug: Sevelamer carbonate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic kidney disease patients aged 18 to 80 years Chronic kidney disease stage 3 (defined as a glomerular filtration rate of 30-60 ml/min/1.73m2) Office blood pressure controlled to less than 140/90 mmHg for 12 months before entry into the study Total cholesterol less than 5.5 mmol/l Exclusion Criteria: Existing or previous treatment within 1 year with a phosphate binder or vitamin D analogue Uncontrolled hyperphosphataemia (serum phosphate >1.8 mmol/l) Uncontrolled secondary hyperparathyroidism (PTH >80 pg/ml) Diabetes mellitus Pregnancy Moderate-severe cardiac valvular disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks | Drug: Sevelamer carbonate<br>* Treatment group: treatment with 1600mg tablets of sevelamer carbonate three times daily for 36 weeks<br>* Other names: Sevelamer carbonate (Renvela);|
| Placebo Comparator: 2<br>Treatment group: treatment with tablets of placebo three times daily for 36 weeks | Drug: Placebo<br>* Treatment group: treatment with tablets of placebo three times daily for 36 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricular mass |  | 36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic compliance as measured by cardiac magnetic resonance imaging |  | 36 weeks | 
| Arterial stiffness as measured by pulse wave velocity and pulse wave analysis |  | 36 weeks | 
| Arterial elastance as measured by echocardiography |  | 36 weeks | 
| Left ventricular systolic and diastolic elastance measured by echocardiography |  | 36 weeks | 
| Bone density on dual-energy x-ray absorptiometry scanning |  | 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Phosphate