Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
NCT ID: NCT00853242
Last Updated: 2015-05-01
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
349 participants
INTERVENTIONAL
2009-02-28
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
NCT00681941
Evaluation of Renvela in Patients With Chronic Kidney Disease Not On Dialysis And Hyperphosphatemia In China
NCT03001011
PA21 Safety and Efficacy in Adult Chinese Subjects
NCT03644264
Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
NCT01857024
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
NCT00267514
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
Placebo
Genz-644470 2.4 Grams Per Day (g/day)
Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470
Genz-644470 4.8 g/day
Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470
Genz-644470 7.2 g/day
Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Genz-644470
Sevelamer Carbonate 2.4 g/day
Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer carbonate
Sevelamer Carbonate 4.8 g/day
Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer carbonate
Sevelamer Carbonate 7.2 g/day
Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
Sevelamer carbonate
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo
Genz-644470
Sevelamer carbonate
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Men or women 18 years or older
Exclusion Criteria
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Monitor
Role: STUDY_DIRECTOR
Genzyme, a Sanofi Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 D.C., 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
Brooklyn, New York, United States
Buffalo, New York, United States
New York, New York, United States
Port Washington, New York, United States
The Bronx, 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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
APB00108
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.