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Clinical experience with Repotin, a locally produced recombinant human erythropoietin, in the treatment of anaemia of chronic renal failure in South Africa
Abstract
Objective. 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).
Design. The study consisted of two multicentre nonrandomised open stages.
Setting. Renal units at several teaching hospitals inSouth Africa.
Participants. 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. Outcome measures. In both stages, outcome was measured by clinical examination, blood pressure, full haematological parameters and blood chemistry.
Results. 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 125lU/kg {average 47.1}.ln 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 aJterations in blood chemistry. The incidence of adverse events reported during the 12-month second stage was no greater than that reported for other fonns of rHuEPO therapy.
Conclusion. Repotin is a safe and effective rHuEPO preparation for the treatment of ACRF.
