Evidence map›Paper›PMID 28339831›Full record

Trial reportNephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association2017

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

Simon D Roger, Carlo A Gaillard, Andreas H Bock, Fernando Carrera, Kai-Uwe Eckardt, David B Van Wyck, Maureen Cronin, Yvonne Meier, Sylvain Larroque, Iain C Macdougall and 1 more

Registry-linked trialOpen access · bronzeAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00994318 (An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose), which is not on this map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00994318 phase3completednot on this map

An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject High and Low Dosage Regimens) Versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease

TypeinterventionalSponsorVifor PharmaRan2009 to 2014Enrolled626ConditionsIron Deficiency Anaemia, Chronic Kidney DiseaseArmsFCM (Ferric carboxymaltose) high ferritin target, FCM (Ferric carboxymaltose) low ferritin target, Oral Iron (Ferrous sulphate)
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 50 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Safety and efficacy of iron isomaltoside 1000/ferric derisomaltose versus iron sucrose in patients with chronic kidney disease: the FERWON-NEPHRO randomized, open-label, comparative trial.Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association · 2021
    Trial
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Erythropoiesis-independent effects of iron in chronic kidney disease.Pediatric nephrology (Berlin, Germany) · 2022
    Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Intravenous Irons: From Basic Science to Clinical Practice.Pharmaceuticals (Basel, Switzerland) · 2018
    Review
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 6 countries.

Simon D RogerRenal Research, Gosford, NSW, Australia.
Carlo A GaillardDepartment of Nephrology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Andreas H BockDepartment of Nephrology, Kantonsspital, Aarau, Switzerland.
Fernando CarreraDepartment of Dialysis, Eurodial, DaVita, Leiria, Portugal.
Kai-Uwe EckardtDepartment of Nephrology and Hypertension, University of Erlangen-Nürnberg, Erlangen, Germany.
David B Van WyckClinical Support Services, Davita Healthcare Partners, Denver, CO, USA.
Maureen CroninVifor Pharma Ltd, Glattbrugg, Switzerland.
Yvonne MeierVifor Pharma Ltd, Glattbrugg, Switzerland.
Sylvain LarroqueVifor Pharma Ltd, Glattbrugg, Switzerland.
Iain C MacdougallDepartment of Renal Medicine, King's College Hospital, London, UK.
FIND-CKD Study Investigators
Gosford Hospital · AUKantonsspital Aarau · CHDaVita Clinical Research (United States) · USKing's College Hospital · GBUniversity Medical Center Groningen · NLVifor Pharma (Switzerland) · CHFriedrich-Alexander-Universität Erlangen-Nürnberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsFIND-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.

resultsThe 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.

conclusionsThese results further support the conclusion that correction of iron deficiency anemia with IV FCM is safe in patients with nondialysis-dependent CKD.

Indexed as

Administration, IntravenousAdministration, OralAgedAnemia, Iron-DeficiencyFemaleFerric CompoundsGlomerular Filtration RateHumansIronMaleMaltoseProspective StudiesRenal Insufficiency, ChronicTime Factorsferric carboxymaltoseFerric CompoundsIronMaltoseanemiacardiovascular diseaseoxidative stress

Identifiers

PMID28339831
PMCPMC5837517
OpenAlexW2466262792

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.