Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis

Study Overview
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Brief Summary
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The purpose of this clinical study is to compare the effects of Genz-644470 with the effects of placebo and sevelamer carbonate (Renvela®) on the reduction of serum phosphorus in hyperphosphatemic chronic kidney disease participants on hemodialysis.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis

Conditions
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Kidney Failure, Chronic

Intervention / Treatment
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* Drug: Placebo
* Drug: Genz-644470
* Drug: Sevelamer carbonate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Serum phosphate level greater than (>) 5.5 milligram per deciliter (mg/dL) (1.78 millimole per liter [mmol/L]) after discontinuation of current phosphate binder therapy Men or women 18 years or older Exclusion Criteria: Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks. | Drug: Placebo<br> <br> |
| Experimental: Genz-644470 2.4 Grams Per Day (g/day)<br>Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Genz-644470<br> <br> |
| Experimental: Genz-644470 4.8 g/day<br>Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Genz-644470<br> <br> |
| Experimental: Genz-644470 7.2 g/day<br>Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Genz-644470<br> <br> |
| Active Comparator: Sevelamer Carbonate 2.4 g/day<br>Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Sevelamer carbonate<br> <br> * Other names: Renvela®;|
| Active Comparator: Sevelamer Carbonate 4.8 g/day<br>Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Sevelamer carbonate<br> <br> * Other names: Renvela®;|
| Active Comparator: Sevelamer Carbonate 7.2 g/day<br>Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks. | Drug: Sevelamer carbonate<br> <br> * Other names: Renvela®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) |  | Baseline, Day 22 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) |  | Baseline, Day 22 | 
| Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 |  | Baseline, Day 22 | 
| Change From Baseline in Total Cholesterol at Day 22 |  | Baseline, Day 22 | 
| Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 |  | Baseline, Day 22 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Kidney Disease, Phosphate Binder, Phosphate, Hyperphosphatemia