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

Kidney Failure, Chronic Clinical Trial

— LEAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00853242
• Other study ID #: APB00108
• Status: Completed
• Phase: Phase 2
• First received: February 27, 2009
• Last updated: April 15, 2015
• Start date: February 2009
• Est. completion date: August 2009

Study information

• Verified date: April 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Placebo

• Genz-644470

• Sevelamer carbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)		Baseline, Day 22	No
Secondary	Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)		Baseline, Day 22	No
Secondary	Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22		Baseline, Day 22	No
Secondary	Change From Baseline in Total Cholesterol at Day 22		Baseline, Day 22	No
Secondary	Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22		Baseline, Day 22	No