학술논문

Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial
Document Type
Academic Journal
Author
Roger, Simon D.Gaillard, Carlo A.Bock, Andreas H.Carrera, FernandoEckardt, Kai-UweVan Wyck, David B.Cronin, MaureenMeier, YvonneLarroque, SylvainMacdougall, Iain C.Gilles, AlastairFaull, RandallToussaint, Nigel D.McMahon, LawrenceSuranyi, MichaelMudge, DavidHutchison, BrianIrish, AshleyKerr, PeterKulkarni, HemantElder, GrahameJardine, MargaretLhotta, KarlMayer, GertVanholder, RaymondMaes, Bart DirkEvenepoel, PieterDebelle, FrédéricJadoul, MichelDratwa, MaxMacel, IgorDunaj, MilanKvapil, MilanBucek, PetrRehorova, JitkaHruby, AlesHonová, VáclavaMalanova, LadaLucak, MartinLecian, DaliborJirovec, MartinVlasak, JiriRychlik, IvanSurel, StanislavKamper, Anne-LiseOstergaard, OveSteffensen, Gudrun KChenine, LeilaChoukroun, GabrialZaoui, PhilippeWanner, ChristophBacks, WolfgangKraatz, UweDellanna, FrankBusch, KlausMarsen, TobiasSeeger, WolfgangWoitas, RainerObermueller, NicholasHaak, ThomasLueders, StephanPistrosch, FrankMueller, EckhardMertens, Peter R.Sutermer, WernerGrebe, Scott-OliverHafezi-Rachti, SyrusRoeser, SilkeTsakiris, DimitriosMemmos, DimitriosVlachakos, DemetriosVargemezis, VassilisStefanidis, IoannisSyrganis, ChristosAlivanis, PolichronisPapadakis, IoannisPapagalanis, NickolaosAndrikos, AimiliosGoumenos, DimitriosSiamopoulos, KostasGouva, CharikeliaPapadakis, GabrielBoletis, IoannisTsimnadi-Spanoudaki, MyrsiniStamatiades, DimitriosStamatelou, KyriakiMoutafis, SpyridonLocatelli, FrancescoSantoro, AntonioQuarello, FrancescoRemuzzi, GiuseppeCoppola, SalvatoreMortellaro, Rosella FerraroIcardi, AndreaColussi, GiacomoGrotta, Franco DellaLombardi, LuigiGallieni, MaurizioVilla, GiuseppeGrandaliano, GiuseppeGaillard, CarloHuisman, SebastiaanBarendregt, JosSmak Gregoor, Peter JHOien, CeciliaRutkowski, BoleslawMalecki, RobertNowicki, MichalRutkowski, PrzemyslawMarczewski, KryzsztofMysliwiec, MichalSydor, AntoniRysz, JacekRydzewski, AndrzejKlinger, MarianWnuk, RafalKozminski, PiotrNocon, AnnaCiechanowski, KazimierzCorreia, PedroNeves, FernandoBarata, JoséMircescu, GabrielVoiculescu, MihaiGluhovschi, GheorgheMota, EugenDe Francisco, Angel Luís MartínTorre, AlbertoHerreros, AlbaLuño, JoséGruss, E.Martins, JudithVallés, MartiPascual, JulioBárány, PeterAmbuehl, Patrice M.Erturk, SehsuvarArici, MustafaPaydas, SaimeSoypacaci, ZekiCamsari, TanerUstundag, SedatThomas, Mark E.DʼSouza, Richard J.Taylor, Jo E.Pritchard, Nicholas R.Jeffery, RobinRiley, Stephen G.Bhatnagar, DeepakBhandari, SunilReaich, DavidStevens, Paul E.El Kossi, MohsenRoe, SimonCamilleri, BrianAhmed, AimunKhwaja, ArifThompson, BarbaraBanerjee, DebasishNicholas, JohannHutchison, AlastairBorrows, Richard
Source
Nephrology Dialysis Transplantation. Sep 01, 2017 32(9):1530-1539
Subject
Language
English
ISSN
0931-0509
Abstract
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 μg/L) or lower (100–200 μg/L) ferritin, or oral iron. A post hoc analysis of adverse event rates per 100 patient-years was performed to assess the safety of FCM versus 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 ≥800 μg/L occurred in 26.6% of high ferritin FCM patients, with no associated increase in adverse events. No patient with ferritin ≥800 μg/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.