Nephrology Dialysis Transplantation, Vol 12, Issue 8 1640-1644, Copyright © 1997 by Oxford University Press
S Burke, E Slatopolsky and D Goldberg
Background: Available phosphate binders contain
aluminium or calcium which can be associated with undesirable effects.
RenaGel®, cross-linked poly(allyl-amine hydrochloride) is a
non-absorbed phosphate binding polymer, free of calcium and aluminium. We
conducted this study to examine the safety and phosphate binding efficacy
of RenaGel in volunteers. Method: During 18 days (days
0-17) at the clinical study unit, 24 subjects consumed a
phosphate-controlled diet designed to provide 37.5 mmol (1200 mg) elemental
phosphorus per day. From the morning of day 5 to the morning of day 9,
urine and faeces were collected. Average base line urine and faecal
phosphorus contents were determined. On days 9-16, the subjects received
either RenaGel 1 g, 2.5 g, or 5 g or placebo three times per day
immediately prior to the meals. From the morning of day 13 to the morning
of day 17, urine and faeces were again collected and phosphorus contents on
treatment were determined. Results: RenaGel inhibited
dietary phosphate absorption as measured by a decline in average daily
urinary phosphorus excretion and an increase in average daily fecal
phosphorus excretion. Average urine phosphorus contents on treatment were
2.7.2 mmol (870 mg) per day in the placebo group vs 23.8 mmol (762 mg),
19.5 mmol (625 mg), and 16.6 mmol (530 mg) per day in the renaGel 1-g,
2.5-g, and 5-g groups. Average daily faecal phosphorus content on treatment
was markedly higher in the RenaGel 5-g group, 19.1 mmol (611 mg) per day vs
10.7 mmol (342 mg) per day for the placebo group. RenaGel also decreased
total serum cholesterol by 0.71 mmol/L (27.5 mg/dl), 0.55mmol/l (21.3
mg/dl), and 1.08 mmol/l (41.8 mg/dl for the RenaGel 1-g,and 5-g groups.
RenaGel was well tolerated with adverse events similar to placebo.
Conclusion: RenaGel is a safe, effective, and well
tolerated phosphate binder in normal volunteers. The degree of phosphate
binding is consistent with its potential use as a phosphate binder in renal
failure patients. Keywords: hyperphosphataemia;
poly(allylamine hydrochloride); phosphate binder; renal failure; serum
cholesterol
ORIGINAL ARTICLES
RnaGel®, a novel calcium- and aluminium-free phosphate binder, inhibits phosphate absorption in normal volunteers
GelTex Pharmaceuticals, Inc., 303 Bear Hill Road, Waltham, MA 02154, USA; Washington University School of Medicine, St Louis, USA; Corresponding author
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