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Clinical Trial Details

Trial ID: L0465
Source ID: NCT00853242
Associated Drug: Placebo
Title: Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
Acronym: LEAP
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00853242/results
Conditions: Kidney Failure, Chronic
Interventions: DRUG: Placebo|DRUG: Genz-644470|DRUG: Sevelamer carbonate
Outcome Measures: Primary: Change From Baseline in Serum Phosphorus at Day 22 (Genz-644470 vs Placebo), Baseline, Day 22 | Secondary: 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
Sponsor/Collaborators: Sponsor: Genzyme, a Sanofi Company
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 349
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2009-02
Completion Date: 2009-08
Results First Posted: 2015-05-01
Last Update Posted: 2015-05-01
Locations: Alexander City, Alabama, United States|Birmingham, Alabama, United States|Hot Springs, Arkansas, United States|Bakersfield, California, United States|Los Angeles, California, United States|Paramount, California, United States|Pembroke Pines, California, United States|Porterville, California, United States|Riverside, California, United States|San Dimas, California, United States|Whittier, California, United States|Denver, Colorado, United States|Washington, District of Columbia, United States|Hudson, Florida, United States|Ocala, Florida, United States|Tampa, Florida, United States|Augusta, Georgia, United States|Marietta, Georgia, United States|Gurnee, Illinois, United States|Indianapolis, Indiana, United States|Wichita, Kansas, United States|Lexington, Kentucky, United States|Bethesda, Maryland, United States|Pontiac, Michigan, United States|Southfield, Michigan, United States|Brookhaven, Mississippi, United States|Gulfport, Mississippi, United States|St Louis, Missouri, United States|Kearney, Nebraska, United States|Las Vegas, Nevada, United States|Bellmore, New York, United States|Bronx, New York, United States|Brooklyn, New York, United States|Buffalo, New York, United States|New York, New York, United States|Port Washington, New York, United States|Asheville, North Carolina, United States|Cincinnati, Ohio, United States|Doylestown, Pennsylvania, United States|Lancaster, Pennsylvania, United States|Lewistown, Pennsylvania, United States|Philadelphia, Pennsylvania, United States|Charleston, South Carolina, United States|Orangeburg, South Carolina, United States|Sumter, South Carolina, United States|Columbia, Tennessee, United States|Knoxville, Tennessee, United States|Nashville, Tennessee, United States|Houston, Texas, United States|Alexandria, Virginia, United States|Glendale, Wisconsin, United States|Milwaukee, Wisconsin, United States|San Juan, Puerto Rico
URL: https://clinicaltrials.gov/show/NCT00853242

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress