We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853242
First Posted: March 2, 2009
Last Update Posted: May 1, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
  Purpose
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.

Condition Intervention Phase
Kidney Failure, Chronic Drug: Placebo Drug: Genz-644470 Drug: Sevelamer carbonate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Sanofi ( Genzyme, a Sanofi Company ):

Primary Outcome Measures:
  • Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) [ Time Frame: Baseline, Day 22 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 349
Study Start Date: February 2009
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Drug: Placebo
Experimental: Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Experimental: Genz-644470 4.8 g/day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Experimental: Genz-644470 7.2 g/day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Genz-644470
Active Comparator: Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Name: Renvela®
Active Comparator: Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Name: Renvela®
Active Comparator: Sevelamer Carbonate 7.2 g/day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Drug: Sevelamer carbonate
Other Name: Renvela®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853242


  Show 53 Study Locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
Study Director: Medical Monitor Genzyme, a Sanofi Company
  More Information

Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT00853242     History of Changes
Other Study ID Numbers: APB00108
First Submitted: February 27, 2009
First Posted: March 2, 2009
Results First Submitted: April 15, 2015
Results First Posted: May 1, 2015
Last Update Posted: May 1, 2015
Last Verified: April 2015

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Chronic Kidney Disease
Phosphate Binder
Phosphate
Hyperphosphatemia

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Urologic Diseases
Sevelamer
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action