The purpose of this study is to determine if sevelamer carbonate powder is an effective treatment for the control of serum phosphorous levels in patients on dialysis when compared to sevelamer hydrochloride tablets.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
31
sevelamer carbonate powder dosed TID with meals for four weeks followed by sevelamer hydrochloride tablets dosed TID with meals for four weeks
sevelamer hydrochloride tablets dosed TID with meals for four weeks followed by sevelamer carbonate powder dosed TID with meals for four weeks
Southmead Hospital
Bristol, United Kingdom
Addenbrooks NHS Trust
Cambridge, United Kingdom
The Royal London Hospital
London, United Kingdom
Guy's Hospital
London, United Kingdom
Demonstrate the equivalence of sevelamer carbonate powder to sevelamer hydrochloride tablets dosed three times per day (TID) with meals on the control of serum phosphorus levels
Time frame: Up to 13 weeks
Evaluate the safety and tolerability of sevelamer carbonate powder compared to sevelamer hydrochloride tablets dosed TID with meals
Time frame: Up to 13 weeks
Compare the effects of sevelamer carbonate powder to sevelamer hydrochloride tablets when dosed three times a day with meals on: serum calcium-phosphorus product
Time frame: Up to 13 weeks
serum lipid profile (total cholesterol, high density lipoprotein [HDL] and low density lipoprotein [LDL] and triglycerides)
Time frame: Up to 13 weeks
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Manchester Royal Infirmary
Manchester, United Kingdom
Hope Hospital
Manchester, United Kingdom
Norfolk and Norwich University Hospital
Norwich, United Kingdom