Swanepoel C R, Moosa M R, Rowland G F, Meyers A M, Botha B P, Smart A J, Goodman R, Schall R, Keogh H J, Merrifield E H
Department of Medicine, University of Cape Town.
S Afr Med J. 1996 Oct;86(10):1266-9.
To evaluate the efficacy and safety of Repotin, a locally produced recombinant human erythropoietin (rHuEPO), in the treatment of the anaemia of chronic renal failure (ACRF).
The study consisted of two multicentre non-randomised open stages.
Renal units at several teaching hospitals in South Africa.
Haemodialysis patients with haemoglobin (Hb) levels less than 8.0 g/dl were recruited. The first stage examined 26 patients during a 12-week period in which the dose of intravenous rHuEPO was adjusted according to haematological response. In the second stage 27 patients were stabilised with intravenous rHuEPO and then maintained at a Hb level above 8.0 g/dl by subcutaneous administration for up to 1 year.
In both stages, outcome was measured by clinical examination, blood pressure, full haematological parameters and blood chemistry.
In stage 1, all patients responded to therapy with a statistically significant increase in Hb from geometric means of 6.28 g/dl to 8.50 g/dl (geometric SDs of 1.17 and 1.20 respectively). The doses used ranged from 25 IU to 125 IU/kg (average 47.1). In the second stage, Hb levels reached a mean of 8.06 g/dl (SD 0.9) and were maintained at target range with an average dose of 55.5 IU/kg three times a week. Apart from changes in serum iron, ferritin (associated with increased haematopoiesis) and potassium, there were no significant alterations in blood chemistry. The incidence of adverse events reported during the 12-month second stage was no greater than that reported for other forms of rHuEPO therapy.
Repotin is a safe and effective rHuEPO preparation for the treatment of ACRF.
