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
Abstract 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...
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| Language: | English |
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BMC
2019-03-01
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| Series: | BMC Nephrology |
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| Online Access: | http://link.springer.com/article/10.1186/s12882-019-1209-1 |
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| author | Shubhadeep D. Sinha Vamsi Krishna Bandi Bala Reddy Bheemareddy Pankaj Thakur Sreenivasa Chary Kalpana Mehta Vikranth Reddy Pinnamareddy Rajendra Pandey Subhramanyam Sreepada Santosh Durugkar |
| author_facet | Shubhadeep D. Sinha Vamsi Krishna Bandi Bala Reddy Bheemareddy Pankaj Thakur Sreenivasa Chary Kalpana Mehta Vikranth Reddy Pinnamareddy Rajendra Pandey Subhramanyam Sreepada Santosh Durugkar |
| author_sort | Shubhadeep D. Sinha |
| collection | DOAJ |
| description | Abstract 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. |
| first_indexed | 2024-12-11T20:25:13Z |
| format | Article |
| id | doaj.art-35af966d045948f0b9108d371d0d1c66 |
| institution | Directory Open Access Journal |
| issn | 1471-2369 |
| language | English |
| last_indexed | 2024-12-11T20:25:13Z |
| publishDate | 2019-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Nephrology |
| spelling | doaj.art-35af966d045948f0b9108d371d0d1c662022-12-22T00:51:58ZengBMCBMC Nephrology1471-23692019-03-012011910.1186/s12882-019-1209-1Efficacy, tolerability and safety of darbepoetin alfa injection for the treatment of anemia associated with chronic kidney disease (CKD) undergoing dialysis: a randomized, phase-III trialShubhadeep D. Sinha0Vamsi Krishna Bandi1Bala Reddy Bheemareddy2Pankaj Thakur3Sreenivasa Chary4Kalpana Mehta5Vikranth Reddy Pinnamareddy6Rajendra Pandey7Subhramanyam Sreepada8Santosh Durugkar9Clinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial EstatesClinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial EstatesClinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial EstatesClinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial EstatesClinical Development and Medical Affairs, Hetero Group, Hetero Corporate, 7-2-A2, Industrial EstatesDepartment of Nephrology, B.L.Y Nair HospitalCare HospitalsDepartment of Nephrology, Institute of Post Graduate Medical Education and Research KolkataSri Raghavendra HospitalAshwini Hospital and Ramakanth Heart Care CenterAbstract 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.http://link.springer.com/article/10.1186/s12882-019-1209-1Darbepoetin alfaErythropoietinAnemiaDialysisEnd-stage renal disease |
| spellingShingle | Shubhadeep D. Sinha Vamsi Krishna Bandi Bala Reddy Bheemareddy Pankaj Thakur Sreenivasa Chary Kalpana Mehta Vikranth Reddy Pinnamareddy Rajendra Pandey Subhramanyam Sreepada Santosh Durugkar 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 BMC Nephrology Darbepoetin alfa Erythropoietin Anemia Dialysis End-stage renal disease |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Darbepoetin alfa Erythropoietin Anemia Dialysis End-stage renal disease |
| url | http://link.springer.com/article/10.1186/s12882-019-1209-1 |
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