Study to Compare Sevelamer Carbonate Powder to Sevelamer Hydrochloride Tablets in Patients With CKD on Hemodialysis
- Conditions
- Kidney DiseasesChronic Renal InsufficiencyEnd-Stage Renal Disease
- Interventions
- Registration Number
- NCT00268957
- Lead Sponsor
- Genzyme, a Sanofi Company
- Brief Summary
Approximately 207 patients with chronic kidney disease (CKD) on hemodialysis will be entered into this study at approximately 26 centers in the United States. This study aims to evaluate the safety and efficacy of sevelamer carbonate powder dosed once-a-day (QD) with the largest meal compared to sevelamer hydrochloride tablets dosed three-times-per-day (TID) with meals. The total length of participation is approximately 24 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 217
- On three times per week hemodialysis for three months or longer
- 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
- Active bowel obstruction, dysphagia, swallowing disorder, or severe gastrointestinal (GI) motility disorders
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Sevelamer carbonate (Renvela®) sevelamer carbonate powder 2 Sevelamer hydrochloride (Renagel®) Sevelamer hydrochloride
- Primary Outcome Measures
Name Time Method Demonstrate the efficacy of sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets dosed TID with meals on the control of serum phosphorus Up to 24 weeks Evaluate the safety and tolerability of sevelamer carbonate powder dosed QD with the largest meal compared to sevelamer hydrochloride tablets dosed TID with meals Up to 24 weeks
- Secondary Outcome Measures
Name Time Method Compare sevelamer carbonate powder dosed QD with the largest meal to sevelamer hydrochloride tablets TID with meals on serum calcium-phosphorus product and serum lipid profile Up to 24 weeks
Trial Locations
- Locations (28)
Central Dialysis Center
🇺🇸Atlanta, Georgia, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Crystal Rivers Dialysis Center
🇺🇸Crystal River, Florida, United States
Gadsden Dialysis
🇺🇸Gadsden, Alabama, United States
Nephrology & Hypertension Associates, LTD
🇺🇸Tupelo, Mississippi, United States
Outcomes Research International, Inc.
🇺🇸Hudson, Florida, United States
Hypertension and Nephrology Associates
🇺🇸Eatontown, New Jersey, United States
Lewiston Dialysis Center
🇺🇸Lewistown, Pennsylvania, United States
Southwest Mississippi Nephrology, PLLC
🇺🇸Brookhaven, Mississippi, United States
Atlanta Nephrology Referral Center
🇺🇸Decatur, Georgia, United States
Gambro Healthcare - Charlottesville
🇺🇸Charlottesville, Virginia, United States
Clinical Research Center
🇺🇸Birmingham, Alabama, United States
Renal Research Inc. at the Kidney Institute
🇺🇸Houston, Texas, United States
Indiana University Hospital
🇺🇸Indianapolis, Indiana, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Nephrology Associates, P.C.
🇺🇸Nashville, Tennessee, United States
Kidney and Hypertension Center
🇺🇸Cincinnati, Ohio, United States
Renal Care Group
🇺🇸Cleveland, Ohio, United States
Nephrology Educational Services and Research
🇺🇸Tarzana, California, United States
FMC Marietta
🇺🇸Marietta, Georgia, United States
Holy Cross Renal Care
🇺🇸Mission Hills, California, United States
Ochsner Clinic Foundation, Nephrology Research
🇺🇸New Orleans, Louisiana, United States
Winthrop University Dialysis Center
🇺🇸Mineola, New York, United States
Davita
🇺🇸Bronx, New York, United States
Medical Nephrology Associates
🇺🇸Dyersburg, Tennessee, United States
Horizon Healthcare Associates
🇺🇸Flossmoor, Illinois, United States
Virginia Commonwealth University, Division of Nephrology
🇺🇸Richmond, Virginia, United States
Clinical Research of Tidewater
🇺🇸Norfolk, Virginia, United States