To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
182
The starting dose is a total daily dose of 2250mg of Fosrenol (Lanthanum carbonate) to a maximum dose of 3000mg daily. Chewable tablets will be administered orally with meals in 750mg and 1000mg strength tablets.
The starting dose is a total daily dose of 4800mg of sevelamer hydrochloride up to a maximum of 6400 mg daily. Sevelamer hydrochloride 800mg tablets, administered orally with meals.
Change From Baseline in Serum Phosphorus Levels at 4 Weeks
Time frame: 4 weeks
Change From Baseline in Serum Calcium Levels at 4 Weeks
Time frame: 4 weeks
Levels of Intact Parathyroid Hormone (iPTH) at Baseline and 4 Weeks
Time frame: Baseline and 4 weeks
Patients Achieving Kidney Disease Outcomes Quality Initiative (KDOQI) Target for Serum Phosphorous at 4 Weeks
Kidney Disease Outcomes Quality Initiative (KDOQI) target for serum phosphorous is 3.5 - 5.5 mg/dL (1.13 - 1.77 mmol/L)
Time frame: 4 weeks
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DSI Renal Inc.
Mesa, Arizona, United States
AKDHC Medical Research Services, LLC
Phoenix, Arizona, United States
Southwest Kidney Institute, PLC
Tempe, Arizona, United States
Unnamed facility
Tempe, Arizona, United States
University of Arizona Health Service Center
Tucson, Arizona, United States
Clinical Research Connections
Jonesboro, Arkansas, United States
South Valley Dialysis Center
Encino, California, United States
VA Greater Los Angeles Health Care System, West LA
Los Angeles, California, United States
Apex Research of Riverside
Riverside, California, United States
North Valley Nephrology
Yuba City, California, United States
...and 34 more locations