Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study
Jazyk angličtina Země Německo Médium print-electronic
Typ dokumentu klinické zkoušky, fáze IV, časopisecké články, multicentrická studie, pozorovací studie, práce podpořená grantem
PubMed
26482252
PubMed Central
PMC4756039
DOI
10.1007/s00467-015-3225-0
PII: 10.1007/s00467-015-3225-0
Knihovny.cz E-zdroje
- Klíčová slova
- Adverse events, Anemia, Chronic kidney disease, Darbepoetin alfa, Hemoglobin, Pediatric,
- MeSH
- anemie krev diagnóza farmakoterapie etiologie MeSH
- biologické markery krev MeSH
- časové faktory MeSH
- chronická renální insuficience krev komplikace diagnóza terapie MeSH
- darbepoetin alfa škodlivé účinky terapeutické užití MeSH
- dialýza ledvin * škodlivé účinky MeSH
- dítě MeSH
- hematinika škodlivé účinky terapeutické užití MeSH
- hemoglobiny metabolismus MeSH
- kojenec MeSH
- krevní transfuze MeSH
- lidé MeSH
- mladiství MeSH
- předškolní dítě MeSH
- prospektivní studie MeSH
- registrace MeSH
- rizikové faktory MeSH
- věkové faktory MeSH
- výsledek terapie MeSH
- Check Tag
- dítě MeSH
- kojenec MeSH
- lidé MeSH
- mladiství MeSH
- mužské pohlaví MeSH
- předškolní dítě MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze IV MeSH
- multicentrická studie MeSH
- pozorovací studie MeSH
- práce podpořená grantem MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- biologické markery MeSH
- darbepoetin alfa MeSH
- hematinika MeSH
- hemoglobiny MeSH
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.
Hannover Medical School Hannover Germany
Medical University of Innsbruck Innsbruck Austria
University Hospital Bonn Bonn Germany
University Hospital Motol Prague Czech Republic
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