EFFECTS OF RECOMBINANT-HUMAN-ERYTHROPOIETIN ON RENAL-FUNCTION IN CHRONIC-RENAL-FAILURE PREDIALYSIS PATIENTS

A study was undertaken to ascertain the effects of recombinant human e rythropoietin (r-HuEPO) on renal function in chronic renal failure pre dialysis patients. The effect of improvement of anemia by r-HuEPO on t he rate of decline in renal function in predialysis patients has not b een previously studied prospectively in a large number of patients usi ng reliable measures of glomerular filtration rate (GFR). To investiga te the efficacy, safety, and impact of r-HuEPO therapy in chronic rena l insufficiency patients, a 48-week, randomized, open-label, multicent er study was initiated in 83 anemic, predialysis (serum creatinine 3 t o 8 mg/dL) patients. Serial GFRs were measured using I-125-iothalamate clearance. Forty patients were randomized to the untreated arm and 43 patients to the treatment arm (50 U/kg r-HuEPO subcutaneously three t imes weekly). Baseline characteristics were comparable for the r-HuEPO -treated and untreated groups. During this 48-week study, GFR, mean ar terial blood pressure, and daily protein intake were not significantly different between the two groups. There was a statistically significa nt increase in hematocrit for the r-HuEPO-treated group that was not a ssociated with acceleration of deterioration in residual renal functio n. This was demonstrated by the lack of a significant (P = 0.376) betw een-group difference in mean change in GFR from baseline to last avail able value for the r-HuEPO-treated (-2.1 +/- 3.2 mL/min) and untreated (-2.8 +/- 3.5 mL/min) groups. This study concludes that r-HuEPO thera py improves anemia in predialysis patients and does not accelerate the rate of progression to end-stage renal disease. (C) 1994 by the Natio nal Kidney Foundation, Inc.