Effects of recombinant human erythropoietin on renal function in chronic renal failure predialysis patients

Am J Kidney Dis. 1994 Nov;24(5):777-84. doi: 10.1016/s0272-6386(12)80671-8.

Abstract

A study was undertaken to ascertain the effects of recombinant human erythropoietin (r-HuEPO) on renal function in chronic renal failure predialysis patients. The effect of improvement of anemia by r-HuEPO on the rate of decline in renal function in predialysis patients has not been previously studied prospectively in a large number of patients using reliable measures of glomerular filtration rate (GFR). To investigate the efficacy, safety, and impact of r-HuEPO therapy in chronic renal insufficiency patients, a 48-week, randomized, open-label, multicenter study was initiated in 83 anemic, predialysis (serum creatinine 3 to 8 mg/dL) patients. Serial GFRs were measured using 125I-iothalamate clearance. Forty patients were randomized to the untreated arm and 43 patients to the treatment arm (50 U/kg r-HuEPO subcutaneously three times weekly). Baseline characteristics were comparable for the r-HuEPO-treated and untreated groups. During this 48-week study, GFR, mean arterial blood pressure, and daily protein intake were not significantly different between the two groups. There was a statistically significant increase in hematocrit for the r-HuEPO-treated group that was not associated with acceleration of deterioration in residual renal function. This was demonstrated by the lack of a significant (P = 0.376) between-group difference in mean change in GFR from baseline to last available 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 therapy improves anemia in predialysis patients and does not accelerate the rate of progression to end-stage renal disease.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anemia / blood
  • Anemia / drug therapy*
  • Anemia / etiology
  • Anemia / physiopathology
  • Blood Pressure / drug effects
  • Erythropoietin / pharmacology*
  • Erythropoietin / therapeutic use
  • Female
  • Glomerular Filtration Rate / drug effects*
  • Humans
  • Iodine Radioisotopes
  • Iothalamic Acid
  • Kidney Failure, Chronic / blood
  • Kidney Failure, Chronic / complications
  • Kidney Failure, Chronic / physiopathology*
  • Male
  • Middle Aged
  • Prospective Studies
  • Recombinant Proteins / pharmacology
  • Recombinant Proteins / therapeutic use
  • Statistics as Topic

Substances

  • Iodine Radioisotopes
  • Recombinant Proteins
  • Erythropoietin
  • Iothalamic Acid