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Efficacy and Tolerability of Sevelamer Carbonate in Hyperphosphatemic Patients Who Have Chronic Kidney Disease and Are Not on Dialysis

Markus Ketteler^*, Marianne Rix, Stanley Fan, Nicholas Pritchard, Ove Oestergaard^||, Scott Chasan-Taber^¶, Jeremy Heaton^¶, Ajay Duggal^¶, and Philip A. Kalra^**

^* Department of Nephrology and Clinical Immunology, University Hospital, Aachen, Germany; Department of Nephrology, Rigshospitalet, Copenhagen, Denmark; Renal Department, Royal London Hospital, London; Department of Nephrology, Addenbrookes Hospital, Cambridge, United Kingdom; ^|| Department of Nephrology, Roskilde Hospital, Roskilde, Denmark; ^¶ Genzyme Corporation, Cambridge, United Kingdom; and ^** Department of Renal Medicine, Hope Hospital, Salford, United Kingdom

Correspondence: Prof. Markus Ketteler, Nephrologische Klinik, Klinikum Coburg gGmbH, Ketschendorfer Strasse 33, 96450 Coburg, Germany. Phone: +49-9561-249611; Fax: +49-9561-249612; E-mail: markus.ketteler{at}klinikum-coburg.de

Background and objectives: Sevelamer carbonate is an improved, buffered form of sevelamer hydrochloride developed for the treatment of hyperphosphatemia in patients with chronic kidney disease. This study investigated the ability of sevelamer carbonate to control serum phosphorous in hyperphosphatemic patients who had chronic kidney disease and were not on dialysis.

Design, setting, participants, & measurements: This was an open-label, dosage-titration study. Patients with serum phosphorus 5.5 mg/dl were enrolled (n = 46). Sevelamer carbonate was administered for 8 wk. Patients were supplemented with native vitamin D (400 IU). The primary efficacy parameter was the change from baseline in serum phosphorous. Secondary measures included the percentage of serum phosphorus responders; changes in serum lipids, calcium-phosphorus product, and bicarbonate; and safety and tolerability.

Results: Sevelamer carbonate treatment resulted in a statistically significant decrease in mean serum phosphorous levels from baseline to end of treatment. A total of 75% of patients with stage 4 and 70% of patients with stage 5 chronic kidney disease achieved the target serum phosphorous at the end of treatment. There were statistically significant decreases in serum calcium-phosphorus product and total and low-density lipoprotein cholesterol at the end of treatment and a statistically significant increase in mean serum bicarbonate levels (from 16.6 to 18.2 mEq/L). Sevelamer carbonate was well tolerated.

Conclusions: Sevelamer carbonate is an effective and well-tolerated therapy for the control of phosphorous levels in hyperphosphatemic patients who have chronic kidney disease and are not on dialysis.