Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
NCT ID: NCT00268957
Last Updated: 2014-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
217 participants
INTERVENTIONAL
2006-01-31
2007-05-31
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.
Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate
NCT00440648
Study to Demonstrate Equivalence of Sevelamer Carbonate Powder and Sevelamer HCl Tablets in Haemodialysis Patients
NCT00267514
Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing
NCT00324376
An Open Label Dose Titration of Sevelamer Carbonate Tabs 3 Times a Day in Hyperphosphatemic CKD Patients Not On Dialysis
NCT00681941
Randomized Study Comparing Genz-644470, Placebo, and Sevelamer Carbonate in Chronic Kidney Disease Patients on Hemodialysis
NCT00853242
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
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
sevelamer carbonate powder
Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
2
Sevelamer hydrochloride
Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sevelamer carbonate (Renvela®)
sevelamer carbonate powder dosed once per day with largest meal
Sevelamer hydrochloride (Renagel®)
Sevelamer hydrochloride tablets dosed three times a day with meals
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Currently on a phosphate binder(s)
* Considered compliant with phosphate binders and hemodialysis therapy
* Willing to avoid any intentional changes in diet such as fasting or dieting
* Have the following documented local laboratory measurements:a.Two most recent consecutive serum phosphorus measurements that are ≥ 3.0 and ≤ 6.5 (6.5) mg/dL within 60 days of screening; b.A most recent intact parathyroid hormone (iPTH) measurement ≤ 800 pg/mL within 90 days of screening
* Have the following central laboratory measurements: a.A serum phosphorus measurement \> 5.5 mg/dL at randomization (Week 0);b.A serum iPTH measurement ≤ 800 pg/mL at screening
* Have not participated in any other investigational drug studies within 30 days prior to enrollment
* Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel
* Willing and able to take sevelamer alone as a phosphate binder for the duration of the study
* Willing and able to maintain screening doses of lipid medication for the duration of the study, except for safety reasons
* Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study unless prescribed as an evening calcium supplement
* If female and of childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout the study, which includes barrier methods, hormones, or intrauterine devices (IUDs)
* Life expectancy of 12 months or greater
* Willing and able to provide informed consent
Exclusion Criteria
* Active ethanol or drug abuse, excluding tobacco use
* In the opinion of the Investigator, subject has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
* Use of anti-arrhythmic or anti-seizure medications for the use of arrhythmia or seizure disorders
* Known hypersensitivity to sevelamer or any constituents of the study drug
* Pregnant or breast-feeding
* Evidence of active malignancy except for basal cell carcinoma of the skin
* Unable to comply with the requirements of the study
* Any other condition which, in the opinion of the Investigator, will prohibit the subject's inclusion in the study
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.
Genzyme Corporation
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.
Clinical Research Center
Birmingham, Alabama, United States
Gadsden Dialysis
Gadsden, Alabama, United States
Holy Cross Renal Care
Mission Hills, California, United States
Nephrology Educational Services and Research
Tarzana, California, United States
Crystal Rivers Dialysis Center
Crystal River, Florida, United States
Outcomes Research International, Inc.
Hudson, Florida, United States
Central Dialysis Center
Atlanta, Georgia, United States
Atlanta Nephrology Referral Center
Decatur, Georgia, United States
FMC Marietta
Marietta, Georgia, United States
Horizon Healthcare Associates
Flossmoor, Illinois, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Ochsner Clinic Foundation, Nephrology Research
New Orleans, Louisiana, United States
Henry Ford Hospital
Detroit, Michigan, United States
Southwest Mississippi Nephrology, PLLC
Brookhaven, Mississippi, United States
Nephrology Associates, P.C.
Columbus, Mississippi, United States
Nephrology & Hypertension Associates, LTD
Tupelo, Mississippi, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hypertension and Nephrology Associates
Eatontown, New Jersey, United States
Winthrop University Dialysis Center
Mineola, New York, United States
Davita
The Bronx, New York, United States
Kidney and Hypertension Center
Cincinnati, Ohio, United States
Renal Care Group
Cleveland, Ohio, United States
Lewiston Dialysis Center
Lewistown, Pennsylvania, United States
Medical Nephrology Associates
Dyersburg, Tennessee, United States
Nephrology Associates, P.C.
Nashville, Tennessee, United States
Renal Research Inc. at the Kidney Institute
Houston, Texas, United States
Gambro Healthcare - Charlottesville
Charlottesville, Virginia, United States
Clinical Research of Tidewater
Norfolk, Virginia, United States
Virginia Commonwealth University, Division of Nephrology
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GD3-199-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.