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


METHODS
The study consisted of two multicentre non-randomised open stages.


METHODS
Renal units at several teaching hospitals in South Africa.


METHODS
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.


METHODS
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 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.


CONCLUSIONS
Repotin is a safe and effective rHuEPO preparation for the treatment of ACRF.
Swanepoel
C R
CR
Department of Medicine, University of Cape Town.
Moosa
M R
MR
Rowland
G F
GF
Meyers
A M
AM
Botha
B P
BP
Smart
A J
AJ
Goodman
R
R
Schall
R
R
Keogh
H J
HJ
Merrifield
E H
EH
D000328:Adult; D000740:Anemia / Q000097:blood / Q000188:drug therapy / Q000209:etiology; D004274:DNA, Recombinant; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D005260:Female; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use; D006435:Renal Dialysis / Q000191:economics; D013019:South Africa
D004274:DNA, Recombinant; D006454:Hemoglobins; D011994:Recombinant Proteins; D004921:Erythropoietin