Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
LEAP
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study Using Genz-644470 and Sevelamer Carbonate in Hyperphosphatemic Chronic Kidney Disease Patients on Hemodialysis
1 other identifier
interventional
349
2 countries
53
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
Shorter than P25 for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 27, 2009
CompletedFirst Posted
Study publicly available on registry
March 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedResults Posted
Study results publicly available
May 1, 2015
CompletedMay 1, 2015
April 1, 2015
6 months
February 27, 2009
April 15, 2015
April 15, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo)
Baseline, Day 22
Secondary Outcomes (4)
Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Sevelamer Carbonate)
Baseline, Day 22
Change From Baseline in Serum Calcium (Albumin-adjusted)-Phosphorus Product at Week 22
Baseline, Day 22
Change From Baseline in Total Cholesterol at Day 22
Baseline, Day 22
Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol at Day 22
Baseline, Day 22
Study Arms (7)
Placebo
PLACEBO COMPARATORPlacebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Genz-644470 2.4 Grams Per Day (g/day)
EXPERIMENTALGenz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 4.8 g/day
EXPERIMENTALGenz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470 7.2 g/day
EXPERIMENTALGenz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 2.4 g/day
ACTIVE COMPARATORSevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 4.8 g/day
ACTIVE COMPARATORSevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer Carbonate 7.2 g/day
ACTIVE COMPARATORSevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Have active dysphagia or swallowing disorder or a predisposition to or current bowel obstruction, ileus, or severe gastrointestinal motility disorders including severe constipation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Unknown Facility
Alexander City, Alabama, United States
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Hot Springs, Arkansas, United States
Unknown Facility
Bakersfield, California, United States
Unknown Facility
Los Angeles, California, United States
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Paramount, California, United States
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Pembroke Pines, California, United States
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Porterville, California, United States
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Riverside, California, United States
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San Dimas, California, United States
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Whittier, California, United States
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Denver, Colorado, United States
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Washington D.C., District of Columbia, United States
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Hudson, Florida, United States
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Ocala, Florida, United States
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Tampa, Florida, United States
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Augusta, Georgia, United States
Unknown Facility
Marietta, Georgia, United States
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Gurnee, Illinois, United States
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Indianapolis, Indiana, United States
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Wichita, Kansas, United States
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Lexington, Kentucky, United States
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Bethesda, Maryland, United States
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Pontiac, Michigan, United States
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Southfield, Michigan, United States
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Brookhaven, Mississippi, United States
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Gulfport, Mississippi, United States
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St Louis, Missouri, United States
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Kearney, Nebraska, United States
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Las Vegas, Nevada, United States
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Bellmore, New York, United States
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Brooklyn, New York, United States
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Buffalo, New York, United States
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New York, New York, United States
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Port Washington, New York, United States
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The Bronx, New York, United States
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Asheville, North Carolina, United States
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Cincinnati, Ohio, United States
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Doylestown, Pennsylvania, United States
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Lancaster, Pennsylvania, United States
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Lewistown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Charleston, South Carolina, United States
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Orangeburg, South Carolina, United States
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Sumter, South Carolina, United States
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Columbia, Tennessee, United States
Unknown Facility
Knoxville, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Alexandria, Virginia, United States
Unknown Facility
Glendale, Wisconsin, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
San Juan, Puerto Rico
Related Publications (1)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Trial Transparency Team
- Organization
- Sanofi
Study Officials
- STUDY DIRECTOR
Medical Monitor
Genzyme, a Sanofi Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2009
First Posted
March 2, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2009
Study Completion
August 1, 2009
Last Updated
May 1, 2015
Results First Posted
May 1, 2015
Record last verified: 2015-04