EFFECT-KTx

Description

Background: Whether correction of iron deficiency improves functional outcomes after kidney transplantation is unknown. We evaluated intravenous ferric carboxymaltose for improving exercise capacity in iron-deficient kidney transplant recipients. In this multicentre, double-blind, randomised, placebo-controlled trial, adult kidney transplant recipients with iron deficiency (ferritin <100 μg/L or 100-299 μg/L with transferrin saturation <20%) at least six months post-transplantation were recruited at two Dutch university hospitals between 7 October 2019 and 16 February 2024. Participants were assigned (1:1) to four intravenous doses of 500 mg ferric carboxymaltose or placebo at six-week intervals. The primary outcome was the between-group difference in 24-week change in 6-min walk test distance. Secondary outcomes included cardiac, kidney, muscle and cognitive function and quality of life. Efficacy was analysed by assigned treatment in 148 participants, with a per-protocol sensitivity analysis; safety analyses included 154 dosed participants. The trial was registered at ClinicalTrials.gov (NCT03769441).

General Design

Type: Clinical trial
Data collection type: Prospective
Design: Longitudinal
Design description: In this multicentre, double-blind, randomised, placebo-controlled trial, adult kidney transplant recipients with iron deficiency (ferritin <100 μg/L or 100-299 μg/L with transferrin saturation <20%) at least six months post-transplantation were recruited at two Dutch university hospitals between 7 October 2019 and 16 February 2024. Participants were assigned (1:1) to four intravenous doses of 500 mg ferric carboxymaltose or placebo at six-week intervals. The primary outcome was the between-group difference in 24-week change in 6-min walk test distance. Secondary outcomes included cardiac, kidney, muscle and cognitive function and quality of life. Efficacy was analysed by assigned treatment in 148 participants, with a per-protocol sensitivity analysis; safety analyses included 154 dosed participants.
Start/End data collection: 2019 until 2024
PID: https://doi.org/10.34760/6ac4c80c437cb
External identifiers: EUDRACT number: 2018-002571-18, METc number: 2018/482, Clinical Trials.gov: NCT03769441

Population

Countries: Netherlands (the)
Number of participants: 154
Number of participants with samples: 148
Population age groups: Adult (18+ years)
Inclusion criteria: Age group inclusion criterion
Defined population inclusion criterion
Other inclusion criteria: - Kidney transplant recipient - Iron deficiency at two consecutive measurements with an interval of at least a week, defined as plasma ferritin<100 μg/L or plasma ferritin 100–299 μg/L with transferrin saturation <20% - ≥6 months after kidney transplantation - ≥18 years of age - Ability to comply with the study protocol - Informed consent
Other exclusion criteria: - Known intolerance to intravenous iron products - Severe (haemoglobin<10·5 g/dL) or progressive anaemia (haemoglobin decline of ≥3·2 g/dL in 2 months) or a reduced mean corpuscular erythrocyte volume (<80 fL) - Recent history of gastrointestinal or urogenital blood loss or a positive faecal occult blood test - Erythrocyte transfusion ≤6 weeks prior to inclusion - Polycythaemia (haemoglobin>15·3 g/dL) or a known history of haemochromatosis - Estimated glomerular filtration rate of ≤30 mL/min per 1·73 m2 - Symptomatic coronary artery disease or myocardial infarction ≤4 weeks prior to inclusion - Disability to walk - Severe hypophosphataemia (plasma phosphate <0·35 mmol/L) ≤4 weeks prior to inclusion - For women at childbearing age: pregnancy or disagreement to take adequate contraceptive precautions - Signs of an active systemic infection - Participation in another intervention study

Organisations

Lead organisations

University Medical Center Groningen (UMCG)
nephrology
Netherlands (the)
https://www.umcg.nl
Data originator

Contributors

prof. dr. MH (Martin) de de BorstUniversity Medical Center Groningenm.h.de.borst@umcg.nl
Principal Investigator, Project leader
drs. JSJ (Anna-Sophie) VinkeUniversity Medical Center Groningenj.s.j.vinke@umcg.nl
Project manager, Researcher

Subpopulations

List of subpopulations for this resource

Name	Description	Number of participants
No results for current selection

Networks

Part of networks

University Medical Center Groningen
Network details

Publications

Intravenous ferric carboxymaltose and exercise capacity in iron-deficient kidney transplant recipients: a randomised, placebo-controlled trial in the Netherlands

Access conditions

on request

Data access conditions: health or medical or biomedical research
disease specific research
Data access fee: false
Release type: Periodically
Release description: on request

Funding & Acknowledgements

Funding: Dutch Kidney Foundation, Dutch Heart Foundation, CSL Vifor.
Acknowledgements: We thank Wendy Dam, Dominique Faessen and Roelie Karsten for their organizational support. We thank Sebastiaan Bensink, Evanne Bolhuis, Noa van Dijk, Ilona Eising, Wouter Elling, Ruth Feenstra, Jesse Grooten, Emma Hoeksema, Erika van der Horst, Miriam Leijzer, Milou Reijnen, Maaike Sikkema, Velda Tjalma, Angela Voskuilen and Jasmijn Wieringa for their effort and execution of the neuropsychological examinations. This project is funded by the Dutch Kidney Foundation (grant no. 17OKG18), the Dutch Heart Foundation (Reconnext Fellowship, grant no. 20241085) and CSL Vifor.