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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT00853242
First received: February 27, 2009
Last updated: April 15, 2015
Last verified: April 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

Primary Outcome Measures:
  • Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo) [ Time Frame: Baseline, Day 22 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate) [ Time Frame: Baseline, Day 22 ] [ Designated as safety issue: No ]
  • Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22 [ Time Frame: Baseline, Day 22 ] [ Designated as safety issue: No ]
  • Change From Baseline in Total Cholesterol at Day 22 [ Time Frame: Baseline, Day 22 ] [ Designated as safety issue: No ]
  • Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22 [ Time Frame: Baseline, Day 22 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00853242

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

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT00853242     History of Changes
Other Study ID Numbers: APB00108
Study First Received: February 27, 2009
Results First Received: April 15, 2015
Last Updated: April 15, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Chronic Kidney Disease
Phosphate Binder
Phosphate
Hyperphosphatemia

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

ClinicalTrials.gov processed this record on July 30, 2015