title: Investigation of the efficacy of a biogeneric recombinant human erythropoietin alfa in the management of renal anemia in patients on hemodialysis: a multi-center clinical trial.
abstract: 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.
authors.affiliation: Nephrology and Urology Research Center, Baqiyatallah University of Medical Sciences, Tehran, Iran.
authors.forename: Fatemeh
authors.initials: F
authors.lastname: Beiraghdar
authors.forename: Yunes
authors.initials: Y
authors.lastname: Panahi
authors.forename: Behzad
authors.initials: B
authors.lastname: Einollahi
authors.forename: Eghlim
authors.initials: E
authors.lastname: Nemati
authors.forename: Mohammad Hassan
authors.initials: MH
authors.lastname: Ghadiani
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Sahebkar
authors.forename: Nader
authors.initials: N
authors.lastname: Maghsoudi
authors.forename: Eisa Tahmasbpour
authors.initials: ET
authors.lastname: Marzony
mesh_terms: D000740:Anemia / Q000188:drug therapy* / Q000209:etiology; D004921:Erythropoietin / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000150:complications / Q000628:therapy*; D008297:Male; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis
chemical_list: D011994:Recombinant Proteins; D004921:Erythropoietin