drugset / Trial / NCT04959578
Comparison of Darbepoetin Alpha and Recombinant Human Erythropoietin for Treatment of Anemia in Children With Chronic Kidney Disease
RandomizedParallel-groupOpen-labelTreatment
Summary
The present study was designed to determine whether or not darbepoetin alfa is non-inferior to recombinant human erythropoietin in the treatment of anemia in children with chronic kidney disease stage 3-5 (on or not on dialysis).
Timeline
- Start
- 2018-02-01
- Primary completion
- 2019-01-31
- Completion
- 2019-01-31
Outcome
Met primary endpoint
paper was well above the pre-specified non-inferiority margin of - 1.0 g/dL. PMID 36220980 ↗
paper DA is non-inferior to rHuEPO for the treatment of anemia of CKD (stage 3-5) in pediatric population PMID 36220980 ↗
Publications
- Background Warady BA, Arar MY, Lerner G, Nakanishi AM, Stehman-Breen C. Darbepoetin alfa for the treatment of anemia in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2006 Aug;21(8):1144-52. doi: 10.1007/s00467-006-0071-0. Epub 2006 May 25.
- Background Koshy SM, Geary DF. Anemia in children with chronic kidney disease. Pediatr Nephrol. 2008 Feb;23(2):209-19. doi: 10.1007/s00467-006-0381-2. Epub 2007 Jan 24.
- Background Klang B, Bjorvell H, Clyne N. Quality of life in predialytic uremic patients. Qual Life Res. 1996 Feb;5(1):109-16. doi: 10.1007/BF00435975.
- Background Gerson A, Hwang W, Fiorenza J, Barth K, Kaskel F, Weiss L, Zelikovsky N, Fivush B, Furth S. Anemia and health-related quality of life in adolescents with chronic kidney disease. Am J Kidney Dis. 2004 Dec;44(6):1017-23. doi: 10.1053/j.ajkd.2004.08.024.
- Background Mitsnefes MM, Daniels SR, Schwartz SM, Meyer RA, Khoury P, Strife CF. Severe left ventricular hypertrophy in pediatric dialysis: prevalence and predictors. Pediatr Nephrol. 2000 Sep;14(10-11):898-902. doi: 10.1007/s004670000303.
- Background Chavers BM, Herzog CA. The spectrum of cardiovascular disease in children with predialysis chronic kidney disease. Adv Chronic Kidney Dis. 2004 Jul;11(3):319-27. doi: 10.1053/j.arrt.2004.04.002.
- Background Pickett JL, Theberge DC, Brown WS, Schweitzer SU, Nissenson AR. Normalizing hematocrit in dialysis patients improves brain function. Am J Kidney Dis. 1999 Jun;33(6):1122-30. doi: 10.1016/S0272-6386(99)70150-2.
- Background Pattaragarn A, Warady BA, Sabath RJ. Exercise capacity in pediatric patients with end-stage renal disease. Perit Dial Int. 2004 May-Jun;24(3):274-80.
- Background Sietsema KE, Hiatt WR, Esler A, Adler S, Amato A, Brass EP. Clinical and demographic predictors of exercise capacity in end-stage renal disease. Am J Kidney Dis. 2002 Jan;39(1):76-85. doi: 10.1053/ajkd.2002.29884.
- Background Xia H, Ebben J, Ma JZ, Collins AJ. Hematocrit levels and hospitalization risks in hemodialysis patients. J Am Soc Nephrol. 1999 Jun;10(6):1309-16. doi: 10.1681/ASN.V1061309.
- Background Ma JZ, Ebben J, Xia H, Collins AJ. Hematocrit level and associated mortality in hemodialysis patients. J Am Soc Nephrol. 1999 Mar;10(3):610-9. doi: 10.1681/ASN.V103610.
- Background Warady BA, Ho M. Morbidity and mortality in children with anemia at initiation of dialysis. Pediatr Nephrol. 2003 Oct;18(10):1055-62. doi: 10.1007/s00467-003-1214-1. Epub 2003 Jul 23.
- Background VanDeVoorde RG, Warady BA. Management of chronic kidney disease. In: Avner ED, Harmon WE, Niaudet P, Yoshikawa N (eds). Pediatric Nephrology, 6th edn. Springer-Verlag, Berlin, 2009; 1661-92.
- Background Lerner G, Kale AS, Warady BA, Jabs K, Bunchman TE, Heatherington A, Olson K, Messer-Mann L, Maroni BJ. Pharmacokinetics of darbepoetin alfa in pediatric patients with chronic kidney disease. Pediatr Nephrol. 2002 Nov;17(11):933-7. doi: 10.1007/s00467-002-0932-0. Epub 2002 Sep 14.
- Mazahir R, Anand K, Pruthi PK. Comparison of darbepoetin alpha and recombinant human erythropoietin for treatment of anemia in pediatric chronic kidney disease: a non-inferiority trial from India. Eur J Pediatr. 2023 Jan;182(1):101-109. doi: 10.1007/s00431-022-04650-1. Epub 2022 Oct 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Darbepoetin alfa | Protein / enzyme biologic | — | Subcutaneous |
| Comparator | recombinant human erythropoietin | Protein / enzyme biologic | — | Subcutaneous |