Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company ) Identifier:
First received: February 27, 2009
Last updated: February 10, 2014
Last verified: February 2014

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
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


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

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
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 identifier: NCT00853242

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

No publications provided

Responsible Party: Sanofi ( Genzyme, a Sanofi Company ) 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

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Urologic Diseases
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Sequestering Agents processed this record on March 03, 2015