Dose-Titration Study of Sevelamer Carbonate in Chronic Kidney Disease (CKD) Patients on Hemodialysis

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy and safety of sevelamer carbonate in reducing serum phosphorus and serum lipids (total and LDL-cholesterol) in Chronic Kidney Disease Patients on dialysis.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study of Sevelamer Carbonate in CKD Patients on Hemodialysis

Conditions
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Chronic Kidney Disease, Chronic Kidney Disease on Hemodialysis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: On hemodialysis regimen scheduled for four hour duration three times per week for a minimum 30 days prior to Visit 1 and throughout the study Have a central laboratory serum iPTH measurement less than 1000 pg/mL at Visit 1 Have a central laboratory serum phosphorus measurement greater than 5.5 mg/dL at Visit 1a Exclusion Criteria: Active dysphagia or swallowing disorder; or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal (GI) motility disorders including severe constipation Documented poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any clinically significant unstable medical condition

Ages Eligible for Study
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Minimum Age: 18 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sevelamer carbonate<br>Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. | Drug: Sevelamer carbonate<br>* Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals. If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals.<br>* Other names: Renvela;|
| Placebo Comparator: Placebo<br>Subjects randomized by a central randomization system to one of two treatment groups in a 2:1 (active: placebo) fashion, stratified by Visit 1a phosphorus result (>5.5 mg/dL-6.5 mg/dL versus greater than 6.5 mg/dL), and site. | Drug: Placebo<br>* Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals. If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Visit 6/Early Termination (ET) in serum phosphorous. |  | 8 weeks | 
| Frequency of treatment-emergent adverse events (AEs) and serious adverse events (SAEs), changes in laboratory parameters, and changes in vital signs. |  | 11 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Visit 6/ET in serum lipids (total cholesterol and LDL-cholesterol). |  | 8 weeks | 

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