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 ORIGINAL ARTICLE
Year : 2012  |  Volume : 22  |  Issue : 3  |  Page : 189-192

Sevelamer carbonate experience in Indian end stage renal disease patients


1 Dialysis Unit, Tamilnad Kidney Research Foundation, Kilpauk, Chennai, India
2 Department of Nephrology and Transplant Medicine, Fortis Hospital, New Delhi, India
3 Department of Nephrology, Pusphawati Singhania Research Institute, New Delhi, India
4 Department of Nephrology, Ezhil Hospital, Tondiarpet, Chennai, India
5 Department of Nephrology, Shree Samarth Hospital, Hrishikesh Medical Foundation 9, Nasik, India
6 Department of Nephrology, Janaki Hospital, Aurangabad, India
7 Department of Nephrology, JSS Hospital, Mysore, Karnataka, India

Correspondence Address:
G Abraham
Tamilnad Kidney Research Foundation, No. 766, Poonamalli High Road, Kilpauk, Chennai 600 010
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0971-4065.98754

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This open label, multicentric, comparative clinical trial was done to compare the efficacy and tolerability of two sevelamer formulations, sevelamer carbonate, and sevelamer hydrochloride, in the treatment of hyperphosphatemia in Indian end stage renal disease (ESRD) patients. A total of 97 ESRD patients on hemodialysis, were enrolled. Patients were randomized to receive either sevelamer carbonate or sevelamer hydrochloride. All patients were evaluated every week for 6 weeks for efficacy and safety variables. Total 88 patients completed the study. After 6 weeks of therapy, there were similar reductions (P<0.0001) in mean serum phosphorus and the CaxP product both the groups. The responder rates for test and reference groups were 75%, 68.18% respectively (P=0.3474). The adverse events reported were nausea, abdominal pain/discomfort, heartburn, constipation, diarrhea, increased prothrombin time, and severe arthritis. No serious adverse events were reported. There was no significant difference between the groups for adverse events and the laboratory parameters. From the results of this multicentric, comparative, randomized clinical study on sevelamer carbonate we can recommend that sevelamer carbonate may be used as a phosphate binder in Indian chronic kidney disease patients.






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Indian Journal of Nephrology
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Online since 20th Sept '07