Details

Autor(en) / Beteiligte

• 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

Titel

Clinical experience with Repotin, a locally produced recombinant human erythropoietin, in the treatment of anaemia of chronic renal failure in South Africa

Ist Teil von

• South African medical journal, 1996-10, Vol.86 (10), p.1266-1269

Ort / Verlag

Pinelands: Medical Association of South Africa

Erscheinungsjahr

1996

Quelle

MEDLINE

Beschreibungen/Notizen

• 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.