Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trial.

Autor: Sinha SD; Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India., Bandi VK; Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India., Bheemareddy BR; Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India., Thakur P; Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India. Pankaj.Thakur@heterodrugs.com., Chary S; Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial Estates, Sanath Nagar, Hyderabad, Andhra Pradesh, India., Mehta K; Department of Nephrology, B.L.Y Nair Hospital, A.L Nair Road, Mumbai, Maharashtra, India., Pinnamareddy VR; Care Hospitals, Road No. 1, Banjara Hills, Hyderabad, Andhra Pradesh, India., Pandey R; Department of Nephrology, Institute of Post Graduate Medical Education and Research Kolkata, 244 A.J.C Bose Road, Kolkata, West Bengal, India., Sreepada S; Sri Raghavendra Hospital, 1-7-100, Opp. Round Building, Kamala Nagar, ECIL Cross Road, ECIL, Hyderabad, Andhra Pradesh, 500062, India., Durugkar S; Ashwini Hospital and Ramakanth Heart Care Center, Shivaji Nagar, Nanded, Maharashtra, India.
Jazyk: angličtina
Zdroj: BMC nephrology [BMC Nephrol] 2019 Mar 13; Vol. 20 (1), pp. 90. Date of Electronic Publication: 2019 Mar 13.
DOI: 10.1186/s12882-019-1209-1
Abstrakt: Background: Darbepoetin alfa (DA-α) is a long-acting erythropoiesis-stimulating glycoprotein which has half-life three-fold longer than that of Erythropoietin alfa (EPO). The objective of this study was to compare the efficacy and safety of DA-α injection versus EPO for treating renal anemia amongst Indian patients with end-stage renal disease (ESRD) undergoing dialysis.
Methods: Patients of either gender (aged 18-65 years) with ESRD undergoing dialysis who had hemoglobin (Hb) levels < 10 g/dL after receiving EPO were switched to DA-α (0.45 μg/kg) once weekly subcutaneously or EPO 50 IU/kg thrice weekly subcutaneously (centrally randomized 1:1) for 12-24 weeks (correction phase) followed by 12 weeks maintenance phase (for Hb levels ≥10 g/dL). The primary efficacy endpoint was mean change in Hb level from baseline to end of correction phase.
Results: In the intention-to-treat population (n = 126), the between group difference in mean Hb change was - 0.01 g/dL (95% CI - 0.68 to - 0.66, p = 0.97). After adjusting for covariates, the difference was - 0.2878 g/dL (95% CI -0.936 to0.360). The lower limit of the two-sided 95% CI of primary endpoint was above the pre-specified non-inferiority margin of - 1.0 g/dL. Similar trend of non-inferiority was observed for per-protocol population. Safety profile of DA-α and EPO were observed to be similar.
Conclusion: Our study results demonstrated that for patients with ESRD undergoing dialysis, administering DA-α at lower dose frequency, is equally effective and well tolerated as EPO for treating renal anemia.
Trial Registration: CTRI/2012/07/002835 [Registered on: 27/07/2012]; Trial Registered Prospectively.
Databáze: MEDLINE
Externí odkaz: