Abstract
Anemia is a frequent complication in patients with chronic kidney disease. However, human recombinant erythropoietin (rHu-EPO) has revolutionized the management of anemia in chronically dialyzed patients. Epomax (R) is a new rHu-EPO alfa manufactured in Tunisia (Medis Laboratories). The aim of this study was to evaluate the efficacy and tolerance of Epomax (R) in chronic hemodialysis (HD) patients in a phase-III, multicenter, clinical trial. Fiftythree HD patients (mean age 47.7 +/- 13 years) who received a stable dose of rHu-EPO (Hemax r, a rHu-EPO alfa manufactured by Biosidus Laboratories) subcutaneously were switched to Epomax (R) via the same route of administration. At baseline, the mean systolic pressure was 132 +/- 18 mm Hg and the mean diastolic pressure was 79 +/- 8 mm Hg. The mean blood hemoglobin was 10.2 g/dL and the median ferritin level was 667 ng/mL. After a follow-up of 43 days, the mean blood hemoglobin was 10.5 g/dL under the effect of Epomax (R). There was no significant difference in the mean hemoglobin levels between the treatments with both drugs. Few adverse events were reported during the study. We conclude that Epomax (R) was effective at maintaining the hemoglobin levels at target concentrations and was well tolerated in HD patients.