A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis.
BACKGROUND
Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphataemia in CKD patients. Sevelamer carbonate formulated as a powder for oral suspension presents a novel, patient-friendly alternative to tablet phosphate binders. This study compared the safety and efficacy of sevelamer carbonate powder with sevelamer hydrochloride tablets in CKD patients on haemodialysis.


METHODS
This was a multi-centre, open-label, randomized, crossover design study. Thirty-one haemodialysis patients were randomly assigned to either sevelamer carbonate powder or sevelamer hydrochloride tablets for 4 weeks followed by a crossover to the other regimen for an additional 4 weeks.


RESULTS
The mean serum phosphorus was 1.6 +/- 0.5 mmol/L (5.0 +/- 1.5 mg/dL) during sevelamer carbonate powder treatment and 1.7 +/- 0.4 mmol/L (5.2 +/- 1.1 mg/dL) during sevelamer hydrochloride tablet treatment. Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus; the geometric least square mean ratio was 0.95 (90% CI 0.87-1.03). No statistically significant or clinically meaningful differences were observed in calcium x phosphorus product and lipid levels between sevelamer carbonate powder and sevelamer hydrochloride tablets. Serum bicarbonate levels increased 2.7 +/- 3.7 mmol/L (2.7 +/- 3.7 mEq/L) during sevelamer carbonate treatment. No statistically significant change in bicarbonate was observed during sevelamer hydrochloride treatment. Sevelamer carbonate powder and sevelamer hydrochloride were well tolerated during this study.


CONCLUSIONS
Sevelamer carbonate powder and sevelamer hydrochloride tablets are equivalent in controlling serum phosphorus and well tolerated in CKD patients on haemodialysis. Bicarbonate levels improved only during sevelamer carbonate treatment. Sevelamer carbonate powder should provide a welcomed new option for the treatment of hyperphosphataemia for CKD patients on dialysis.
Fan
Stanley
S
Department of Nephrology, Royal London Hospital, London, UK. s.fan@qmul.ac.uk
Ross
Calum
C
Mitra
Sandip
S
Kalra
Philip
P
Heaton
Jeremy
J
Hunter
John
J
Plone
Melissa
M
Pritchard
Nick
N
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002614:Chelating Agents / Q000008:administration & dosage*; D002908:Chronic Disease; D018592:Cross-Over Studies; D005260:Female; D006801:Humans; D007674:Kidney Diseases / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011073:Polyamines / Q000008:administration & dosage*; D011208:Powders; D011446:Prospective Studies; D006435:Renal Dialysis; D000069603:Sevelamer; D013607:Tablets
D002614:Chelating Agents; D011073:Polyamines; D011208:Powders; D013607:Tablets; D000069603:Sevelamer