Correction of Anaemia of Chronic Renal Failure with Recombinant Human Erythropoietin: Safety and Efficacy of One Year's Treatment in a European Multicentre Study of 150 Haemodialysis-Dependent Patients*

Abstract

One hundred and fifty patients undergoing regular haemodialysis for end-stage renal failure entered a trial of treatment for anaemia with recombinant human erythropoietin (r-HuEPO). At data cut-off 37 patients (24.6%) had dropped out for various reasons; most of them (n=22) discontinued because of kidney transplantation (after 3–17 months of treatment). The initial dose was 24 U/kg i.v. thrice weekly, with subsequent dose escalations after a minimum of 2 weeks if the haemoglobin (Hb) was less than 10% above the pretreatment baseline. One hundred and forty-three patients who were eligible for efficacy analysis achieved an Hb increase of ≥2g/dl, and all 139 patients eligible for ‘full response’ analysis (Hb between 10 and 12 g/dl) were dose titrated to reach this arbitrarily defined optimal range. Patients' response to r-HuEPO treatment was independent of age, weight, nephric state or duration of dialysis treatment. To maintain the Hb within the range of 10–12 g/dl during 1 year's treatment (n=96) a median weekly r-HuEPO dose of 200 U/kg (range 150–300) divided into one, two, or three administrations appeared to be adequate. This maintenance dose depends slightly on the patient's baseline Hb. The study provides evidence that long-term treatment with r-HuEPO is safe. In 48 patients (of whom 12 had no history of hypertension) elevation of blood pressure required additional treatment, which was effective in all but one who was withdrawn from the study. Four patients had seizures and one suffered hypertensive encephalopathy without convulsions. Thrombosis of the vascular access sites occurred in 22 patients, in 16 of whom this coincided with clinically significant increases in haematocrit. No antibodies to r-HuEPO were detected in any patient throughout the entire observation period.