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Nephrology Dialysis Transplantation, Vol 12, Issue 5 961-964, Copyright © 1997 by Oxford University Press

ORIGINAL ARTICLES

Effect of RenaGel®, a non-absorbable, cross-linked, polymeric phosphate binder, on urinary phosphorus excretion in rats

D Rosenbaum, S Holmes-Farley, W Mandeville, M Pitruzzello and D Goldberg
GelTex Pharmaceuticals Inc., Waltham, MA, USA; Corresponding author

Background. Normalization of serum phosphorus is critical in the treatment of End Stage Renal Failure patients. Aluminum or calcium based phosphate binders, while efficacious, are associated with potential adverse side effects and toxicities. We have developed RenaGel®, a novel, non-absorbed hydrogel which binds dietary phosphate leading to increased fecal excretion, decreased absorption and decreased serum phosphorus levels. In this paper, we present results from both in vitro and in vivo studies in which we examined the efficacy of this novel phosphate binder. Methods. In vitro, RenaGel® was suspended in the test solution, and the mixture was stirred for 1 hour at room temperature. The solid was then filtered off, and the residual liquid analyzed for phosphate. In vivo, RenaGel was mixed in rodent feed at different concentrations and fed to normal rats for up to 4 days. Urine was collected and analyzed for phosphate content. Results and conclusions. In vitro binding studies demonstrate that RenaGel has an extremely high phosphate binding capacity. At an estimated physiological concentration of 5 mM phosphate, RenaGel binds 2.6 mmole phosphate/g of phosphate binder. The in vivo binding study shows that RenaGel mixed into the diet increased urinary phosphorus excretion in a dose dependent manner. RenaGel particles with a 23 &mgr;m mean diameter are more efficacious than the larger ones. In conclusion, the above studies indicate that RenaGel is a potent phosphate binder. RenaGel® contains no calcium or aluminum and offers an alternative to existing phosphate binder treatments. Keywords: phosphate binder, hydrogel, end-stage renal failure, hyperphosphatemia, dietary phosphate, particle size, urine phosphate
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