Nephrology Dialysis Transplantation, Vol 13, Issue 9 2303-2310, Copyright © 1998 by Oxford University Press
D Goldberg, M Dillon, E Slatopolsky, B Garrett, J Gray, T Marbury, M Weinberg, D Wombolt and S Burke
Background: Control of dietary phosphate absorption in
end-stage renal disease patients is essential to prevent the deleterious
sequelae of phosphorus retention. Efficacy of currently available calcium-
and aluminium-containing phosphate binders is constrained by the
side-effects associated with the absorption of calcium and aluminium. The
current study examined the efficacy of RenaGel, a calcium- and
aluminium-free, polymeric phosphate binder, in end-stage renal disease
patients. Methods: Administration of calcium- or
aluminium-containing phosphate binders ceased during a 2-week washout
period. RenaGel, at starting doses of one, two, or three 500-mg capsules
three times per day with meals, was administered for 8 weeks. RenaGel dose
was titrated up 1 capsule per meal at the end of each 2-week period if
necessary to achieve phosphorus control. A second 2-week washout period
followed the end of RenaGel treatment. Results: Mean
serum phosphorus rose from a prewashout level of 6.9 mg/dl (2.23 mmol/l) to
8.1 mg/dl (2.62 mmol/l) at the end of the initial 2-week washout. With
RenaGel treatment, serum phosphorus declined and returned to pre-washout
levels after 4 weeks. Serum phosphorus reached a nadir of 6.5 mg/dl (2.10
mmol/l) after 7 weeks of RenaGel treatment. Serum phosphorus rose to 8.2
mg/dl (2.65 mmol/l) 2 weeks after cessation of RenaGel treatment. As
anticipated, calcium declined during the initial washout period when
calcium-based phosphate binders were stopped for the majority of patients.
The rise in serum phosphorus and decline in serum calcium during washout
resulted in an increase in median intact parathyroid hormone (iPTH) levels
from 292 pg/ml to 395 pg/ml. iPTH fell to 283 pg/ml after 6 weeks of
RenaGel treatment despite a persistently lower serum calcium. RenaGel
treatment also reduced serum total and LDL cholesterol by 25 mg/dl (0.65
mmol/l) and 23 mg/dl 0.59 mmol/l) respectively.
Conclusions: RenaGel appears to be an effective
phosphate binder free of calcium and aluminium. Phosphorus control with two
to four RenaGel capsules per meal appears to result in comparable
phosphorus lowering seen with calcium- or aluminium-based phosphate
binders. RenaGel may offer an alternative for the control of phosphorus
retention in end-stage renal disease patients. Key
words: hyperphosphataemia; hyperparathyroidism; chronic renal
disease; randomized controlled trial; cholesterol
ORIGINAL ARTICLES
Effect of RenaGel®, a non-absorbed, calcium- and aluminium-free phosphate binder, on serum phosphorus, calcium, and intact parathyroid hormone in end-stage renal disease patients
GelTex Pharmaceuticals, Inc, Nine Fourth Avenue, Waltham, MA 02154, USA; Renal Division, Department of Internal Medicine, Washington University School of Medicine, St Louis, MO, USA; RenaGel Study Group: Dupont Circle Dialysis Center, Washington, DC, USA; Kidney Disease and Critical Care, Golden Valley, MN, USA; Orlando Clinical Research Center, Orlando, FL, USA; Hypertension and Nephrology Inc., Providence, RI, USA; Clinical Research Associates of Tidewater, Norfolk, VA, USA; Corresponding author
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