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: February 10, 2014
Last verified: February 2014
  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 patients on hemodialysis.


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Genz-644470
Drug: Placebo
Drug: Sevelamer carbonate, Renvela
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 (Genz-644470 and placebo) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Evaluation of safety and tolerability [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from baseline in serum phosphorus (Genz-644470 and sevelamer carbonate) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum calcium-phosphorus product [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in serum lipids [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 349
Study Start Date: February 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Genz-644470, low dose Drug: Genz-644470
low dose
Experimental: Genz-644470, medium dose Drug: Genz-644470
medium dose
Experimental: Genz-644470, high dose Drug: Genz-644470
high dose
Placebo Comparator: 4 Drug: Placebo
Placebo
Active Comparator: Sevelamer carbonate, low dose Drug: Sevelamer carbonate, Renvela
low dose
Active Comparator: Sevelamer carbonate, medium dose Drug: Sevelamer carbonate, Renvela
medium dose
Active Comparator: Sevelamer carbonate, high dose Drug: Sevelamer carbonate, Renvela
high dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Serum phosphate level > 5.5mg/dl (1.78mmol/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
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
Last Updated: February 10, 2014
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

ClinicalTrials.gov processed this record on April 14, 2014