Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study.
BACKGROUND
Limited prospective data are available on the long-term safety of darbepoetin alfa (DA) for treating anemia in children with chronic kidney disease (CKD).


METHODS
In this prospective, phase IV, observational registry study, children ≤16 years of age with CKD anemia and receiving DA were observed for ≤2 years. Adverse events (AEs), DA dosing, hemoglobin (Hb) concentrations, and transfusions were recorded.


RESULTS
A total of 319 patients were included in the analysis (mean age, 9.1 years), 158 (49.5%) of whom were on dialysis at study entry. Of 434 serious AEs reported in 162 children, the most common were peritonitis (10.0%), gastroenteritis (6.0%), and hypertension (4.1%). Six patients (1.9%) died (unrelated to DA). Four patients (1.3%) experienced six serious adverse drug reactions. The geometric mean DA dose range was 1.4-2.0 μg/kg/month. Mean baseline Hb concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively. Overall, 48 patients (15.0%) received ≥1 transfusion.


CONCLUSIONS
No new safety signals for DA were identified in children receiving DA for CKD anemia for ≤2 years. Based on Hb concentrations and transfusion requirements, DA was effective at managing anemia in these patients.
University of Heidelberg, Heidelberg, Germany. franz.schaefer@med.uni-heidelberg.de.|Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, Im Neuenheimer Feld 430, 69120, Heidelberg, Germany. franz.schaefer@med.uni-heidelberg.de.
Franz
F
Schaefer
University Hospital Bonn, Bonn, Germany.
Bernd
B
Hoppe
Medical University of Innsbruck, Innsbruck, Austria.
Therese
T
Jungraithmayr
University of Marburg, Marburg, Germany.
Günter
G
Klaus
Hannover Medical School, Hannover, Germany.
Lars
L
Pape
Amgen (Europe) GmbH, Zug, Switzerland.
Mourad
M
Farouk
Amgen Ltd, Cambridge, UK.
Janet
J
Addison
Amgen Ltd, Cambridge, UK.
Nick
N
Manamley
University Hospital Motol, Prague, Czech Republic.
Karel
K
Vondrak
D000293:Adolescent; D000367:Age Factors; D000740:Anemia / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy* / Q000209:etiology; D015415:Biomarkers / Q000097:blood; D001803:Blood Transfusion; D002648:Child; D002675:Child, Preschool; D000068256:Darbepoetin alfa / Q000009:adverse effects / Q000627:therapeutic use*; D005060:Europe; D005260:Female; D006397:Hematinics / Q000009:adverse effects / Q000627:therapeutic use*; D006454:Hemoglobins / Q000378:metabolism; D006801:Humans; D007223:Infant; D008297:Male; D011446:Prospective Studies; D012042:Registries; D006435:Renal Dialysis / Q000009:adverse effects; D051436:Renal Insufficiency, Chronic / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000628:therapy*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D006397:Hematinics; D006454:Hemoglobins; D000068256:Darbepoetin alfa
Adverse events; Anemia; Chronic kidney disease; Darbepoetin alfa; Hemoglobin; Pediatric