title: Poly[allylamine hydrochloride] (RenaGel): a noncalcemic phosphate binder for the treatment of hyperphosphatemia in chronic renal failure.
abstract: Dietary phosphate restriction and the oral administration of calcium and aluminum salts have been the principal means of controlling hyperphosphatemia in individuals with end-stage renal disease over the past decade. Although relatively well-tolerated, a large fraction of patients treated with calcium develop hypercalcemia, particularly when administered concurrently with calcitriol, despite a lowering of the dialysate calcium concentration. We evaluated the efficacy of cross-linked poly[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 maintenance hemodialysis patients followed over an 8-week period. RenaGel was found to be as effective as calcium carbonate or acetate as a phosphate binder. The reduction in serum phosphorus was significantly greater after 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/dL; P = 0.037). There was no significant change in serum calcium concentration in either treatment group. The total serum cholesterol and low-density lipoprotein cholesterol fraction were significantly reduced in 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 difference 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.
authors.affiliation: Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.
authors.forename: G M
authors.initials: GM
authors.lastname: Chertow
authors.forename: S K
authors.initials: SK
authors.lastname: Burke
authors.forename: J M
authors.initials: JM
authors.lastname: Lazarus
authors.forename: K H
authors.initials: KH
authors.lastname: Stenzel
authors.forename: D
authors.initials: D
authors.lastname: Wombolt
authors.forename: D
authors.initials: D
authors.lastname: Goldberg
authors.forename: J V
authors.initials: JV
authors.lastname: Bonventre
authors.forename: E
authors.initials: E
authors.lastname: Slatopolsky
mesh_terms: D000328:Adult; D000368:Aged; D002214:Capsules; D003131:Combined Modality Therapy; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood*; D011073:Polyamines / Q000008:administration & dosage* / Q000009:adverse effects; D006435:Renal Dialysis; D000069603:Sevelamer; D013997:Time Factors
chemical_list: D002214:Capsules; D005782:Gels; D010710:Phosphates; D011073:Polyamines; D000069603:Sevelamer