Recombinant human erythropoietin has proved to be effective to treat anemia of end-stage renal disease (ESRD). The aim of this study was to assess the efficacy and safety profile of Epotin, a rHuEPO produced in the Middle East. One hundred thirty patients with Hct </= 27%; Hb </= 9 g/dL maintained on hemodialysis thrice weekly from 19centers in eight countries in the Middle East were recruited into this 13-week study. Depleted iron stores (TSTAT <20% and/or Serum ferritin < 100 microg/dL) were replenished prior to initiation of Epotin therapy, which was delivered intravenously in a dose of 150 U/kg body weight/week in three equal doses postdialysis and titrated according to hemoglobin (Hb) and hematocrit (Hct) response. Efficacy was assessed in terms of Hb/Hct response. Epotin raised the mean Hb level from 7.7 (+/- 1.2) g/dL to 12.0 (+/- 1.7) g/dL and Hct from 22.7 (+/- 4.1) % to 36.2 (+/- 5.7) % by week 13. The increase started to show significance at week 3. Targeting an absolute increase in Hb of 2.5 g/dL (Hct 7.5%) over a 13-week period, the success rate was of <85.71%. Segregating patients into subgroups of men and women and chronic ESRD versus recent ESRD failed to reveal a significant differences in either the severity of the anemia or the response to Epotin. Side effects were similar to other erythropoietins; no dropouts were reported. In conclusion, Epotin is effective to treat anemia in patients on maintenance hemodialysis with an acceptable safety profile. No difference in response was observed between men and women, nor between patients with different levels of chronicity of ESRD.