BACKGROUND:Recombinant human erythropoietin (rHuEPO) is the cornerstone therapy for anemia associated with chronic kidney disease. However, not all patients with renal anemia receive sufficient doses of rHuEPO due to its high cost. The present trial aimed to evaluate the efficacy of Epolyrec, a biogeneric rHuEPO, in the management of renal anemia in patients on hemodialysis. METHODS:Seventy-two patients with end stage renal disease (ESRD) who were receiving hemodialysis were assigned to receive Epolyrec subcutaneously at a dose of 40-80 IU/Kg in 2-3 divided doses after each dialysis session for 12 weeks. Hemoglobin, hematocrit, and CBC/DIFF together with biomarkers of iron status, renal function, and trace elements were evaluated at baseline and during the course of trial. RESULTS:Hemoglobin concentrations and hematocrit progressively increased from baseline (8.45 +/- 1.42 mg/dL and 27.05 +/- 4.64% for hemoglobin and hematocrit, respectively) to the end of trial (10.56 +/- 1.93 and 34.06 +/- 6.70) (p < 0.001). RBC count (p = 0.026), reticulocyte count (p = 0.045), and MCV (p < 0.001) were also significantly increased at the end of trial (3.86 +/- 0.91x10(6)/microL, 0.78 +/- 0.31%, and 93.50 +/- 10.90 fL for RBC count, reticulocyte count, and MCV, respectively) compared to baseline (0.98 +/- 3.38, 0.18 +/- 0.63, and 89.75 +/- 9.35). Serum iron and ferritin were decreased while creatinine and phosphorous increased by the end of trial. No significant change was observed in WBC count, RDW, MCH, MCHC, BUN, PTH, Na, Ca, K, and Mg (p > 0.05). The frequencies of evaluated side effects were generally low and < 10%. CONCLUSIONS: Epolyrec is clinically efficacious in the elevation of hemoglobin and hematocrit in anemic ESRD patients receiving hemodialysis. Future comparative trials are warranted to compare the efficacy and safety of Epolyrec to those of innovator products.
RCT Entities:
BACKGROUND: Recombinant humanerythropoietin (rHuEPO) is the cornerstone therapy for anemia associated with chronic kidney disease. However, not all patients with renal anemia receive sufficient doses of rHuEPO due to its high cost. The present trial aimed to evaluate the efficacy of Epolyrec, a biogeneric rHuEPO, in the management of renal anemia in patients on hemodialysis. METHODS: Seventy-two patients with end stage renal disease (ESRD) who were receiving hemodialysis were assigned to receive Epolyrec subcutaneously at a dose of 40-80 IU/Kg in 2-3 divided doses after each dialysis session for 12 weeks. Hemoglobin, hematocrit, and CBC/DIFF together with biomarkers of iron status, renal function, and trace elements were evaluated at baseline and during the course of trial. RESULTS: Hemoglobin concentrations and hematocrit progressively increased from baseline (8.45 +/- 1.42 mg/dL and 27.05 +/- 4.64% for hemoglobin and hematocrit, respectively) to the end of trial (10.56 +/- 1.93 and 34.06 +/- 6.70) (p < 0.001). RBC count (p = 0.026), reticulocyte count (p = 0.045), and MCV (p < 0.001) were also significantly increased at the end of trial (3.86 +/- 0.91x10(6)/microL, 0.78 +/- 0.31%, and 93.50 +/- 10.90 fL for RBC count, reticulocyte count, and MCV, respectively) compared to baseline (0.98 +/- 3.38, 0.18 +/- 0.63, and 89.75 +/- 9.35). Serum iron and ferritin were decreased while creatinine and phosphorous increased by the end of trial. No significant change was observed in WBC count, RDW, MCH, MCHC, BUN, PTH, Na, Ca, K, and Mg (p > 0.05). The frequencies of evaluated side effects were generally low and < 10%. CONCLUSIONS:Epolyrec is clinically efficacious in the elevation of hemoglobin and hematocrit in anemic ESRDpatients receiving hemodialysis. Future comparative trials are warranted to compare the efficacy and safety of Epolyrec to those of innovator products.