title: Sevelamer carbonate experience in Indian end stage renal disease patients.
abstract: 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.
authors.affiliation: Dialysis Unit, Tamilnad Kidney Research Foundation, Kilpauk, Chennai, India.
authors.forename: G
authors.initials: G
authors.lastname: Abraham
authors.forename: V
authors.initials: V
authors.lastname: Kher
authors.forename: S
authors.initials: S
authors.lastname: Saxena
authors.forename: M
authors.initials: M
authors.lastname: Jayakumar
authors.forename: D
authors.initials: D
authors.lastname: Chafekar
authors.forename: P
authors.initials: P
authors.lastname: Pargaonkar
authors.forename: M
authors.initials: M
authors.lastname: Shetty
authors.forename: Y N V
authors.initials: YN
authors.lastname: Reddy
authors.forename: Y N V
authors.initials: YN
authors.lastname: Reddy
keywords: Chronic renal failure; end stage renal disease; hyperphosphatemia; sevelamer carbonate; sevelamer hydrochloride