Efficacy and tolerance of treatment with recombinant-human erythropoietin in chronic renal failure (pre-dialysis) patients.

Recombinant-human erythropoietin (r-HuEPO) was administered to 24 anaemic pre-dialysis patients with end-stage renal disease. R-HuEPO was injected i.v. three times weekly during the first two months (correction phase). Fixed dosages of 50 U/kg, 100 U/kg, and 150 U/kg were used, and each dose group consisted of eight patients. During the subsequent six months r-HuEPO was given once weekly and the dose was adjusted to maintain a stable haemoglobin value (maintenance phase). The mean +/- SD haemoglobin increased from 9.3 +/- 0.6 to 11.1 +/- 1.3 g/dl with 50 U/kg, from 7.9 +/- 1.4 to 11.8 +/- 1.7 g/dl with 100 U/kg and from 8.4 +/- 1.0 to 12.1 +/- 1.1 g/dl with 150 U/kg of r-HuEPO. The two highest dose groups showed a marked reticulocytosis and a transient thrombocytosis. During the maintenance phase haemoglobin remained stable (11.9 +/- 1.1 g/dl) at a mean dose of 199 +/- 139 U/kg of r-HuEPO per week. Blood pressure did not increase, but in nine of eighteen previously hypertensive patients antihypertensive medication was increased. One hypertensive patient developed seizures. No accelerated progression of renal failure could be demonstrated. All patients reported an improved sense of well-being. R-HuEPO is an important new therapeutic agent for the treatment of anaemia of end-stage renal failure that is also effective in pre-dialysis patients.