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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11130/16:10323703

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FG - Pediatrie

OECD FORD obor

—

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2016

Kód důvěrnosti údajů

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

Název periodika

Pediatric Nephrology

ISSN

0931-041X

e-ISSN

—

Svazek periodika

31

Číslo periodika v rámci svazku

3

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

11

Strana od-do

443-453

Kód UT WoS článku

000371425100013

EID výsledku v databázi Scopus

2-s2.0-84958912673