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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
217
sevelamer carbonate powder dosed once per day with largest meal
Sevelamer hydrochloride tablets dosed three times a day with meals
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
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
Time frame: 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
Time frame: Up to 24 weeks
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
Time frame: Up to 24 weeks
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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
...and 19 more locations