Bradley A Warady1, John Barcia2, Nadine Benador3, Augustina Jankauskiene4, Kurt Olson5, Ludmila Podracka6, Aleksey Shavkin7, Poyyapakkam Srivaths8, Cynthia J Wong9, Jeffrey Petersen5. 1. University of Missouri-Kansas City School of Medicine, Children's Mercy Kansas City, Kansas City, MO, 64108, USA. bwarady@cmh.edu. 2. Department of Pediatrics, University of Virginia School of Medicine, Charlottesville, VA, USA. 3. Rady Children's Hospital, University of California at San Diego, San Diego, CA, USA. 4. Center for Pediatrics, Vilnius University, Vilnius, Lithuania. 5. Amgen Inc., Thousand Oaks, CA, USA. 6. 1st Dept Pediatric Children's Hospital, Comenius University, Bratislava, Slovakia. 7. Children's City Hospital #1, St. Petersburg, Russia. 8. Department of Pediatric Medicine - Renal, Texas Children's Hospital, Houston, TX, USA. 9. Division of Pediatric Nephrology, Stanford University, Palo Alto, CA, USA.
Abstract
BACKGROUND:Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS:One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs. no) to receive darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) subcutaneously (not on dialysis and peritoneal dialysis subjects) and intravenously (hemodialysis subjects). The drug was titrated to achieve Hb levels of 10.0-12.0 g/dl over 25 weeks. Patient- and parent-reported health-related outcomes were measured by the Pediatric Quality of Life Inventory (PedsQL™) in children ≥2 years. RESULTS: In both groups, mean Hb concentrations increased to ≥11.0 g/dl over the first 3 months of treatment and remained stable within the 10.0-12.0 g/dl target range. The median time to achieve hemoglobin ≥10 g/dl was slightly longer for subjects <12 years (QW and Q2W, both 28 days) vs. those ≥12 years (23 and 22 days, respectively). Adverse event profiles were similar between groups, with QW, four (7%) and Q2W, five (9%). PedsQL™ scores showed modest increases. CONCLUSIONS:Darbepoetin alfa can be safely administered either QW or Q2W to ESA-naïve pediatric patients with CKD-related anemia to achieve Hb targets of 10.0-12.0 g/dl.
RCT Entities:
BACKGROUND: Darbepoetin alfa is a commonly prescribed erythropoiesis-stimulating agent (ESA) for correcting anemia in pediatric chronic kidney disease (CKD) patients. However, little information exists on its use in ESA-naïve patients. This study evaluated the efficacy and safety of darbepoetin alfa in pediatric patients initiating ESA therapy. METHODS: One-hundred sixteen pediatric ESA-naïve subjects (aged 1-18 years) with CKD stages 3-5D and hemoglobin (Hb) <10 g/dl from 43 centers in the US, Europe, and Mexico were randomized by age (three groups) and dialysis status (yes vs. no) to receive darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) subcutaneously (not on dialysis and peritoneal dialysis subjects) and intravenously (hemodialysis subjects). The drug was titrated to achieve Hb levels of 10.0-12.0 g/dl over 25 weeks. Patient- and parent-reported health-related outcomes were measured by the Pediatric Quality of Life Inventory (PedsQL™) in children ≥2 years. RESULTS: In both groups, mean Hb concentrations increased to ≥11.0 g/dl over the first 3 months of treatment and remained stable within the 10.0-12.0 g/dl target range. The median time to achieve hemoglobin ≥10 g/dl was slightly longer for subjects <12 years (QW and Q2W, both 28 days) vs. those ≥12 years (23 and 22 days, respectively). Adverse event profiles were similar between groups, with QW, four (7%) and Q2W, five (9%). PedsQL™ scores showed modest increases. CONCLUSIONS: Darbepoetin alfa can be safely administered either QW or Q2W to ESA-naïve pediatric patients with CKD-related anemia to achieve Hb targets of 10.0-12.0 g/dl.
Entities:
Keywords:
Anemia; Chronic kidney disease; Darbepoetin alfa; Erythropoiesis-stimulating agent; Pediatric; Quality of life
Authors: J Bahlmann; K H Schöter; P Scigalla; H J Gurland; M Hilfenhaus; K M Koch; F A Muthny; H H Neumayer; W Pommer; E Quelhorst Journal: Contrib Nephrol Date: 1991 Impact factor: 1.580
Authors: Arlene C Gerson; Alicia Wentz; Allison G Abraham; Susan R Mendley; Stephen R Hooper; Robert W Butler; Debbie S Gipson; Marc B Lande; Shlomo Shinnar; Marva M Moxey-Mims; Bradley A Warady; Susan L Furth Journal: Pediatrics Date: 2010-01-18 Impact factor: 7.124