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NDT Advance Access published online on August 7, 2009
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfp372
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© The Author [2009].
Published by Oxford University Press on behalf of the ERA-EDTA. All rights reserved. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses?by-nc/2.0/uk/) which permits unrestricted non-commercial use distribution, and reproduction in any medium, provided the original work is properly cited.


A randomized, crossover design study of sevelamer carbonate powder and sevelamer hydrochloride tablets in chronic kidney disease patients on haemodialysis

Stanley Fan1, Calum Ross2, Sandip Mitra3, Philip Kalra4, Jeremy Heaton5, John Hunter5, Melissa Plone5 and Nick Pritchard6

1 Department of Nephrology, Royal London Hospital, London 2 Department of Nephrology, Norfolk and Norwich University Hospital, Norwich 3 Department of Nephrology, Manchester Royal Infirmary, Manchester 4 Department of Nephrology, Salford Royal Hospital, Salford, UK 5 Clinical Research Department, Genzyme Corporation, Cambridge, MA, USA 6 Department of Nephrology, Addenbrooke's Hospital, Cambridge, UK

Correspondence and offprint requests to: Stanley Fan; E-mail: s.fan{at}qmul.ac.uk



  Abstract

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.

Keywords: clinical trial; haemodialysis patients; phosphate binder; powder formulation; sevelamer carbonate

Received for publication: 18. 2.09
Accepted in revised form: 6. 7.09


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