SAFETY AND EFFICACY OF RECOMBINANT-HUMAN-ERYTHROPOIETIN IN CORRECTINGTHE ANEMIA OF PATIENTS WITH CHRONIC RENAL-ALLOGRAFT DYSFUNCTION

Recombinant human erythropoietin (rHuEPO) is effective in correcting a nemia in hemodialysis, peritoneal dialysis, and predialysis patients. Limited studies in patients with failing renal allografts suggest a si milar efficacy but provide little information concerning benefits, dos e requirements, or adverse events. This study examined these considera tions in a group of 40 patients (18 men; 22 women) aged 40.3 +/- 13.8 yr with stable, chronic renal allograft failure. All patients had a he moglobin <95 g/L and a serum creatinine >250 mu mol/L at baseline. Pat ients received rHuEPO (50 U/kg sc) three times weekly for 24 wk along with iron po if serum ferritin was <100 mu g/L. Mean hemoglobin rose f rom 78.9 +/- 10.4 to 102.6 +/- 18.4 g/L after 24 wk. Mean rHuEPO dose at 24 wk was 129.8 +/- 81.9 U/kg per week. With oral iron supplementat ion only, serum ferritin fell throughout the 24 wk, whereas serum iron , transferrin saturation, and total iron-binding capacity remained sta ble. Quality of life was assessed by use of the general Sickness Impac t Profile and the disease-specific Transplant Disease Questionnaire me asures at baseline and every 8 wk during rHuEPO therapy. Significant i mprovement was noted in global Sickness Impact Profile scores and in f our of five dimensions of the Transplant Disease Questionnaire, Seriou s adverse events were infrequent. No change in mean systolic or diasto lic blood pressure was noted, although there was a significantly incre ased need for antihypertensive drugs in 18 patients (P = 0.0002). A si gnificant inverse correlation was noted between baseline renal functio n and maintenance rHuEPO dose (r = -0.45; P < 0.05), Twelve patients r eturned to dialysis during the study. Compared with the 25 patients wh o completed 24 wk of rHuEPO therapy, these 12 patients had a lower hem oglobin (72.6 +/- 10.6 versus 81.0 +/- 9.1 g/L; P < 0.05), lower creat inine clearance (16.7 +/- 12.0 versus 24.1 +/- 12.4 mL/min per 1.73 m( 2); P < 0.05), and higher serum creatinine (539.7 +/- 156.8 versus 366 .1 +/- 130 mu mol/L; P < 0.05) at baseline. rHuEPO was effective in im proving anemia in patients with failing renal allografts. Dose require ments and quality-of-life benefits were similar to those reported for other renal failure populations. The higher dose of rHuEPO required fo r some patients suggests that rHuEPO may be less effective as GFR fall s. Further data are required to clarify the role of rHuEPO in the prog ression of renal failure in these patients.