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Comparing Therapeutic Efficacy and Safety of Epoetin Beta and Epoetin Alfa in the Treatment of Anemia in End-Stage Renal Disease Hemodialysis Patients Publisher Pubmed



Azmandian J1 ; Abbasi MR2 ; Pourfarziani V3 ; Nasiri AA4 ; Ossareh S5 ; Ezzatzadegan Jahromi S6 ; Sanadgol H5 ; Amini S7 ; Shahvaroughi Farahani A8
Authors
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Authors Affiliations
  1. 1. Department of Nephrology, Kerman University of Medical Sciences, Kerman, Iran
  2. 2. Nephrology Research Center, Tehran University of Medical Sciences, Imam Khomeini Hospital, Keshavarz Boulevard, Tehran, 1419733141, Iran
  3. 3. Nephrology and Urology Research Center, Baqyiatallah University of Medical Sciences, Tehran, Iran
  4. 4. Imam Hossein Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  5. 5. Hasheminejad Kidney Center, Iran University of Medical Sciences, Tehran, Iran
  6. 6. Shiraz Nephro-Urology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran
  7. 7. Head of Medical Department, Orchid Pharmed Company, Tehran, Iran
  8. 8. Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

Source: American Journal of Nephrology Published:2018


Abstract

Background: Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III study aimed to compare the efficacy and safety of CinnaPoietin® (epoetin beta, CinnaGen) with Eprex® (epoetin alfa, Janssen Cilag) in the treatment of anemia in ESRD hemodialysis patients. Methods: In this randomized, active-controlled, double-blind, parallel, and non-inferiority trial, patients were randomized to receive either CinnaPoietin® or Eprex® for a 26-week period. The primary endpoints of this study were to assess the mean hemoglobin (Hb) change during the last 4 weeks of treatment from baseline along with the evaluation of the mean weekly epoetin dosage per kilogram of body weight that was necessary to maintain the Hb level within 10-12 g/dL during the last 4 weeks of treatment. As the secondary objective, safety was assessed along with other efficacy endpoints. Results: A total of 156 patients were included in this clinical trial. There was no statistically significant difference between treatment groups regarding the mean Hb change (p = 0.21). In addition, the mean weekly epoetin dosage per kg of body weight for maintaining the Hb level within 10-12 g/dL showed no statistically significant difference between treatment arms (p = 0.63). Moreover, both products had comparable safety profiles. However, the incidence of Hb levels above 13 g/dL was significantly lower in the CinnaPoietin® group. Conclusion: CinnaPoietin® was proved to be non-inferior to Eprex® in the treatment of anemia in ESRD hemodialysis patients. The trial was registered in Clinicaltrials.gov (NCT03408639). © 2018 S. Karger AG, Basel.
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