Abstract
This pilot study was designed to evaluate the efficacy and acceptability of sevelamer hydrochloride as a phosphate binder in pediatric patients treated with dialysis. A 6-month open-label trial of sevelamer hydrochloride (Renagel) was initiated in 17 patients, aged 11.8±3.7 years, undergoing hemodialysis (n=3) or peritoneal dialysis (n=14). Following a 2-week washout period of the phosphate binders, serum phosphorus increased from 5.2±1.3 mg/dl to 7.5±2.2 mg/dl (P<0.0002). After initiation of therapy with sevelamer hydrochloride, serum phosphorus levels decreased to 6.2±1.2 mg/dl (P<0.01) during the first 8 weeks and final values were 6.3±1.5 mg/dl. Serum calcium concentration decreased during the washout period from 9.4±0.9 mg/dl to 8.9±1.5 mg/dl (P<0.01); values remained unchanged thereafter. The serum calcium-phosphorus ion product decreased during the first 8 weeks and values did not change subsequently. Serum bicarbonate, parathyroid hormone, total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol, and triglyceride levels did not change. The initial prescribed dose of sevelamer hydrochloride was 121±50 mg/kg (4.5±5 g/day) and the final prescribed dose was 163±46 mg/kg (6.7±2.4 g/day). Sevelamer hydrochloride was well tolerated and without adverse effects related to the drug.
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Acknowledgements
This study was supported in part by USPHS grants DK-35423, by GeltTex Pharmaceuticals, and by funds from the Casey Lee Ball Foundation. The results of the study were presented in part at the 2001 American Society of Nephrology Meeting in San Francisco. Dr. Salusky is a consultant for Genzyme Pharmaceutical.
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Mahdavi, H., Kuizon, B.D., Gales, B. et al. Sevelamer hydrochloride: an effective phosphate binder in dialyzed children. Pediatr Nephrol 18, 1260–1264 (2003). https://doi.org/10.1007/s00467-003-1298-7
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DOI: https://doi.org/10.1007/s00467-003-1298-7