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Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study

The result's identifiers

  • Result code in IS VaVaI

    <a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F16%3A10323703" target="_blank" >RIV/00064203:_____/16:10323703 - isvavai.cz</a>

  • Alternative codes found

    RIV/00216208:11130/16:10323703

  • Result on the web

    <a href="http://dx.doi.org/10.1007/s00467-015-3225-0" target="_blank" >http://dx.doi.org/10.1007/s00467-015-3225-0</a>

  • DOI - Digital Object Identifier

    <a href="http://dx.doi.org/10.1007/s00467-015-3225-0" target="_blank" >10.1007/s00467-015-3225-0</a>

Alternative languages

  • Result language

    angličtina

  • Original language name

    Safety and usage of darbepoetin alfa in children with chronic kidney disease: prospective registry study

  • Original language description

    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 mu g/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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

  • CEP classification

    FG - Paediatrics

  • OECD FORD branch

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2016

  • Confidentiality

    S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Data specific for result type

  • Name of the periodical

    Pediatric Nephrology

  • ISSN

    0931-041X

  • e-ISSN

  • Volume of the periodical

    31

  • Issue of the periodical within the volume

    3

  • Country of publishing house

    US - UNITED STATES

  • Number of pages

    11

  • Pages from-to

    443-453

  • UT code for WoS article

    000371425100013

  • EID of the result in the Scopus database

    2-s2.0-84958912673