Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216208%3A11130%2F17%3A10374350" target="_blank" >RIV/00216208:11130/17:10374350 - isvavai.cz</a>

Alternative codes found

RIV/00064203:_____/17:10374350

Result on the web

<a href="https://doi.org/10.1093/ndt/gfw264" target="_blank" >https://doi.org/10.1093/ndt/gfw264</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1093/ndt/gfw264" target="_blank" >10.1093/ndt/gfw264</a>

Result language

angličtina

Original language name

Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial

Original language description

Background. The evidence base regarding the safety of intravenous (IV) iron therapy in patients with chronic kidney disease (CKD) is incomplete and largely based on small studies of relatively short duration. Methods. FIND-CKD (ClinicalTrials. gov number NCT00994318) was a 1-year, open-label, multicenter, prospective study of patients with nondialysis-dependent CKD, anemia and iron deficiency randomized (1: 1: 2) to IV ferric carboxymaltose (FCM), targeting higher (400-600 mg/L) or lower (100-200 mg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCMversus oral iron over an extended period. Results. The safety population included 616 patients. The incidence of one or more adverse events was 91.0, 100.0 and 105.0 per 100 patient-years in the high ferritin FCM, low ferritin FCM and oral iron groups, respectively. The incidence of adverse events with a suspected relation to study drug was 15.9, 17.8 and 36.7 per 100 patient-years in the three groups; for serious adverse events, the incidence was 28.2, 27.9 and 24.3 per 100 patient-years. The incidence of cardiac disorders and infections was similar between groups. At least one ferritin level &gt;= 800 mg/L occurred in 26.6% of high ferritin FCMpatients, with no associated increase in adverse events. No patient with ferritin &gt;= 800 mg/L discontinued the study drug due to adverse events. Estimated glomerular filtration rate remained the stable in all groups. Conclusions. These results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.

Czech name

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Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

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OECD FORD branch

30217 - Urology and nephrology

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2017

Confidentiality

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

Name of the periodical

Nephrology, Dialysis, Transplantation

ISSN

0931-0509

e-ISSN

—

Volume of the periodical

32

Issue of the periodical within the volume

9

Country of publishing house

GB - UNITED KINGDOM

Number of pages

10

Pages from-to

1530-1539

UT code for WoS article

000410084000018

EID of the result in the Scopus database

2-s2.0-85018014099