Clinical Nephrology – Epidemiology – Clinical Trials

Kidney International (2005) 68, 1759–1765; doi:10.1111/j.1523-1755.2005.00592.x

Darbepoetin alfa (Aranesp™) in children with chronic renal failure

DENIS F GEARY, LAURA E KEATING, ANNETTE VIGNEUX, DEREK STEPHENS, DIANE HÉBERT and ELIZABETH A HARVEY

Division of Nephrology, and Department of Population Health Sciences, Hospital for Sick Children, Toronto, Ontario, Canada

Correspondence: Denis F. Geary, Division of Nephrology, Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8 Canada. E-mail: Denis.Geary@sickkids.ca

Received 7 February 2005; Revised 4 April 2005; Accepted 5 May 2005.

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Abstract

Darbepoetin alfa (Aranesp™) in children with chronic renal failure.

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/1.73m2, 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 mug/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 mug/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.

Keywords:

chronic renal failure, darbepoetin alfa, anemia, dialysis, pediatrics

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