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Darbepoetin alfa (Aranesp) in children with chronic renal failure
Denis F Geary1, Laura E Keating, Annette Vigneux
1Division of Nephrology, and Department of Population Health Sciences, Hospital for Sick Children, Toronto, Ontario, Canada. Denis.Geary@sickkids.ca
Insights
Darbepoetin alfa effectively treats anemia in children with chronic renal failure (CRF) at a dose of 0.5 mcg/kg/week. Many children achieved target hemoglobin levels with less frequent injections, demonstrating safety and efficacy.
Area of Science:
- Pediatric Nephrology
- Hematology
- Pharmacology
Background:
- Limited data existed on darbepoetin alfa use in pediatric chronic renal failure (CRF).
- Previous reports included only 7 children with CRF.
- The study aimed to expand on this by evaluating efficacy, safety, and dosing in a larger pediatric cohort.
Purpose of the Study:
- To assess the efficacy and safety of darbepoetin alfa in children with chronic renal insufficiency (CRI).
- To determine an appropriate therapeutic dose for pediatric patients with CRI.
- To evaluate hemoglobin response in children undergoing dialysis (peritoneal dialysis or hemodialysis).
Main Methods:
- A prospective, open-label study enrolled 26 children with CRI (GFR <30 mL/min/1.73 m²).
- Seven ineligible children were analyzed retrospectively.
- The starting dose was 0.45 mcg/kg/week, with a primary outcome of hemoglobin (Hb) response between 10.0-12.5 g/dL.
Main Results:
- Thirty-three children (aged 1-17 years) were included; 10 patients dropped out, none due to the study drug.
- Mean Hb levels were 11.8 and 11.4 g/dL at 8-12 and 20-28 weeks, respectively.
- 97% and 91% of patients achieved Hb >10.0 g/dL in the respective intervals; 87% received injections less than weekly by 28 weeks.
Conclusions:
- Darbepoetin alfa, at approximately 0.5 mcg/kg/week, effectively treats anemia in pediatric patients with CRF.
- The dose can be proportionally increased for many patients.
- Less frequent administration (less than once weekly) is feasible for a significant proportion of children.
Background:
Darbepoetin alfa use has been reported in 7 children with chronic renal failure (CRF). Our objective was to evaluate the efficacy and safety of darbepoetin and determine a therapeutic dose in a larger sample of children with CRF.
Methods:
Twenty-six children with chronic renal insufficiency (CRI) GFR <30 mL/min/1.73 m(2), on peritoneal dialysis (PD) or hemodialysis (HD) entered a prospective, open-label study of darbepoetin. Seven ineligible children who underwent the same evaluation were analyzed retrospectively. The starting dose was 0.45 microg/kg/week. IRB/REB approval and informed consent were obtained. The primary outcome measure was hemoglobin (Hb) response within a target range of 10.0 to 12.5 g/dL between 8 and 12 and 20 and 28 weeks.
Results:
Thirty-three children (15 CRI, 9 HD, 9 PD; aged 1-17 years) were enrolled in the study. Ten patients dropped out (3 before 12 weeks and 7 before 28 weeks), none due to darbepoetin. Mean Hbs were 11.8 and 11.4 between weeks 8 and 12 and 20 and 28, respectively; the proportion of patients with Hb values >10.0 g/dL was 97% and 91% in the same intervals. No effect of grouping patients into CRI, HD, or PD or prospective versus retrospective was observed. One of 13 serious adverse events (hypertension) was possibly related to darbepoetin; 8/14 children reported injection-site pain. At 12 and 28 weeks, respectively, 73% and 87% were receiving darbepoetin less than once weekly.
Conclusion:
A dose approximating 0.5 microg/kg/week of darbepoetin effectively treats anemia in children with chronic renal failure; for many, this may be proportionately increased and injected less than once weekly.
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