Safety of intravenous ferric carboxymaltose versus oral iron in patients with nondialysis-dependent CKD: an analysis of the 1-year FIND-CKD trial
- Roger, Simon D. 6
- Gaillard, Carlo A. 4
- Bock, Andreas H. 8
- Carrera, Fernando 2
- Eckardt, Kai-Uwe 7
- Van Wyck, David B. 3
- Cronin, Maureen 5
- Meier, Yvonne 5
- Larroque, Sylvain 5
- Macdougall, Iain C. 1
- Roger, Simon D.
- Gilles, Alastair
- Faull, Randall
- Toussaint, Nigel D.
- McMahon, Lawrence
- Suranyi, Michael
- Mudge, David
- Hutchison, Brian
- Irish, Ashley
- Kerr, Peter
- Kulkarni, Hemant
- Elder, Grahame
- Jardine, Margaret
- Lhotta, Karl
- Mayer, Gert
- Vanholder, Raymond
- Maes, Bart Dirk
- Evenepoel, Pieter
- Debelle, Frédéric
- Jadoul, Michel
- Dratwa, Max
- Macel, Igor
- Dunaj, Milan
- Kvapil, Milan
- Bucek, Petr
- Rehorova, Jitka
- Hruby, Ales
- Honová, Václava
- Malanova, Lada
- Lucak, Martin
- Lecian, Dalibor
- Jirovec, Martin
- Vlasak, Jiri
- Rychlik, Ivan
- Surel, Stanislav
- Kamper, Anne-Lise
- Ostergaard, Ove
- Steffensen, Gudrun K
- Chenine, Leila
- Choukroun, Gabrial
- Zaoui, Philippe
- Wanner, Christoph
- Backs, Wolfgang
- Kraatz, Uwe
- Dellanna, Frank
- Busch, Klaus
- Marsen, Tobias
- Seeger, Wolfgang
- Woitas, Rainer
- Obermueller, Nicholas
- Haak, Thomas
- Lueders, Stephan
- Pistrosch, Frank
- Mueller, Eckhard
- Mertens, Peter R.
- Sutermer, Werner
- Grebe, Scott-Oliver
- Hafezi-Rachti, Syrus
- Roeser, Silke
- Tsakiris, Dimitrios
- Memmos, Dimitrios
- Vlachakos, Demetrios
- Vargemezis, Vassilis
- Stefanidis, Ioannis
- Syrganis, Christos
- Alivanis, Polichronis
- Papadakis, Ioannis
- Papagalanis, Nickolaos
- Andrikos, Aimilios
- Goumenos, Dimitrios
- Siamopoulos, Kostas
- Gouva, Charikelia
- Papadakis, Gabriel
- Boletis, Ioannis
- Tsimnadi-Spanoudaki, Myrsini
- Stamatiades, Dimitrios
- Stamatelou, Kyriaki
- Moutafis, Spyridon
- Locatelli, Francesco
- Santoro, Antonio
- Quarello, Francesco
- Remuzzi, Giuseppe
- Coppola, Salvatore
- Mortellaro, Rosella Ferraro
- Icardi, Andrea
- Colussi, Giacomo
- Grotta, Franco Della
- Lombardi, Luigi
- Gallieni, Maurizio
- Villa, Giuseppe
- Grandaliano, Giuseppe
- Gaillard, Carlo
- Huisman, Sebastiaan
- Barendregt, Jos
- Smak Gregoor, Peter JH
- Oien, Cecilia
- Rutkowski, Boleslaw
- Malecki, Robert
- Nowicki, Michal
- Rutkowski, Przemyslaw
- Marczewski, Kryzsztof
- Mysliwiec, Michal
- Sydor, Antoni
- Rysz, Jacek
- Rydzewski, Andrzej
- Klinger, Marian
- Wnuk, Rafal
- Kozminski, Piotr
- Nocon, Anna
- Ciechanowski, Kazimierz
- Correia, Pedro
- Neves, Fernando
- Barata, José
- Mircescu, Gabriel
- Voiculescu, Mihai
- Gluhovschi, Gheorghe
- Mota, Eugen
- De Francisco, Angel Luís Martín
- Torre, Alberto
- Herreros, Alba
- Luño, José
- Gruss, E.
- Vallés, Marti
- Pascual, Julio
- Bárány, Peter
- Bock, Andreas H.
- Ambuehl, Patrice M.
- Erturk, Sehsuvar
- Arici, Mustafa
- Paydas, Saime
- Soypacaci, Zeki
- Camsari, Taner
- Ustundag, Sedat
- Macdougall, Iain C.
- Thomas, Mark E.
- D'Souza, Richard J.
- Taylor, Jo E.
- Pritchard, Nicholas R.
- Jeffery, Robin
- Riley, Stephen G.
- Bhatnagar, Deepak
- Bhandari, Sunil
- Reaich, David
- Stevens, Paul E.
- El Kossi, Mohsen
- Roe, Simon
- Camilleri, Brian
- Ahmed, Aimun
- Khwaja, Arif
- Thompson, Barbara
- Banerjee, Debasish
- Nicholas, Johann
- Hutchison, Alastair
- Borrows, Richard
- The FIND-CKD Study Investigators
- Martins, Judith
- Mostrar todos los/as autores/as +
- 1 Department of Renal Medicine, King's College Hospital, London, UK
- 2 Department of Dialysis, Eurodial, DaVita, Leiria, Portugal
- 3 Clinical Support Services, Davita Healthcare Partners, Denver, CO, USA
- 4 Department of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands
- 5 Vifor Pharma Ltd, Glattbrugg, Switzerland
- 6 Renal Research, Gosford, NSW, Australia
- 7 Department of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany
- 8 Department of Nephrology, Kantonsspital, Aarau, Switzerland
ISSN: 0931-0509, 1460-2385
Año de publicación: 2017
Volumen: 32
Número: 9
Páginas: 1530-1539
Tipo: Artículo
Otras publicaciones en: Nephrology Dialysis Transplantation
Resumen
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.
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