De novo weekly and biweekly darbepoetin alfa dosing in pediatric patients with chronic kidney disease.

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.

• Authors: Bradley A Warady, John Barcia, Nadine Benador, Augustina Jankauskiene, Kurt Olson, Ludmila Podracka, Aleksey Shavkin, Poyyapakkam Srivaths, Cynthia J Wong, Jeffrey Petersen
• Journal: Pediatric nephrology (Berlin, Germany) (Pediatr Nephrol) Vol. 33 Issue 1 Pg. 125-137 (Jan 2018) ISSN: 1432-198X [Electronic] Germany
• PMID: 28815341 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Hematinics
• Hemoglobins
• Darbepoetin alfa

Topics

• Adolescent
• Anemia (drug therapy, etiology)
• Child
• Child, Preschool
• Darbepoetin alfa (administration & dosage, adverse effects)
• Double-Blind Method
• Drug Administration Schedule
• Europe
• Female
• Hematinics (administration & dosage, adverse effects)
• Hemoglobins (analysis, drug effects)
• Humans
• Infant
• Male
• Mexico
• Quality of Life
• Renal Dialysis
• Renal Insufficiency, Chronic (complications, drug therapy)
• Survival Analysis
• Treatment Outcome