EFFECT-KTx
Intravenous ferric carboxymaltose and exercise capacity in iron-deficient kidney transplant recipients: a randomised, placebo-controlled trial in the Netherlands.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).
- Type
- Clinical trial
- Design
- Longitudinal
- Participants
- 154
- Duration
- 2019 until 2024