POLY[ALLYLAMINE HYDROCHLORIDE] (RENAGEL) - A NONCALCEMIC PHOSPHATE BINDER FOR THE TREATMENT OF HYPERPHOSPHATEMIA IN CHRONIC-RENAL-FAILURE

Dietary phosphate restriction and the oral administration of calcium a nd aluminum salts have been the principal means of controlling hyperph osphatemia in individuals with end-stage renal disease over the past d ecade. Although relatively well-tolerated, a large fraction of patient s treated with calcium develop hypercalcemia, particularly when admini stered concurrently with calcitriol, despite a lowering of the dialysa te calcium concentration. We evaluated the efficacy of cross-linked po ly[allylamine hydrochloride] (RenaGel; Geltex Pharmaceuticals, Waltham , MA), a nonabsorbable calcium- and aluminum-free phosphate binder, in a randomized, placebo-controlled, double-blind trial of 36 maintenanc e hemodialysis patients followed over an Ei-week period, RenaGel was f ound to be as effective as calcium carbonate or acetate as a phosphate hinder, The reduction in serum phosphorus was significantly greater a fter 2 weeks of treatment with RenaGel (6.6 +/- 2.1 mg/dL to 5.4 +/- 1 .5 mg/dL) compared with placebo (7.0 +/- 2.1 mg/dL to 7.2 +/- 2.4 mg/d L; P = 0.037). There was no significant change in serum calcium concen tration in either treatment group, The total serum cholesterol and low -density lipoprotein cholesterol fraction were significantly reduced i n RenaGel-treated patients compared with placebo-treated patients (P = 0.013 and P = 0.003, respectively) without a concomitant reduction in high-density lipoprotein cholesterol (P = 0.93), There was no differe nce among recipients of RenaGel and placebo in terms of adverse events , RenaGel is a safe and effective alternative to oral calcium for the management of hyperphosphatemia in end-stage renal disease. (C) 1997 b y the National Kidney Formation, Inc.