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

Genzyme, a Sanofi Company349 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

349

Conditions

Kidney Failure, Chronic

Interventions

PlaceboDRUG

Genz-644470DRUG

Sevelamer carbonateDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (53)

Outcomes

Primary Outcomes

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)

Time frame: Baseline, Day 22

Secondary Outcomes

Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)

Time frame: Baseline, Day 22

Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22

Time frame: Baseline, Day 22

Change From Baseline in Total Cholesterol at Day 22

Time frame: Baseline, Day 22

Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22

Time frame: Baseline, Day 22

Data from ClinicalTrials.gov

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Unnamed facility

Alexander City, Alabama, United States

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Birmingham, Alabama, United States

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Hot Springs, Arkansas, United States

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Bakersfield, California, United States

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Los Angeles, California, United States

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Paramount, California, United States

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Pembroke Pines, California, United States

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Porterville, California, United States

Unnamed facility

Riverside, California, United States

Unnamed facility

San Dimas, California, United States

...and 43 more locations