PALADIN—intravenous iron strategies for the management of anaemia in adults receiving peritoneal dialysis: rationale and design of a randomised controlled feasibility trial

Introduction Anaemia and iron deficiency are common in chronic kidney disease and peritoneal dialysis (PD), contributing to impaired quality of life, physical function, and cognitive performance. While intravenous (IV) iron is established in haemodialysis, evidence in PD is limited and guideline recommendations remain extrapolated and conservative. Existing PD trials have focused largely on biochemical outcomes, with short follow-up and limited assessment of patient-reported outcomes. This feasibility randomised controlled trial aims to assess the practicality, safety, and preliminary efficacy of proactive high-dose versus reactive low-dose IV iron compared with oral iron in adults receiving PD, to inform the design of a definitive multi-centre trial. Methods PALADIN ( p ro a ctive high-dose versus l ow- d ose reactive intravenous or oral i ro n in people on peritoneal dialysis) is a multi-centre, open-label, three-arm feasibility randomised controlled trial. Adults receiving PD are randomised 1:1:1 to proactive high-dose IV iron, reactive low-dose IV iron, or oral iron therapy. Participants attend visits at baseline and 3, 6, 9, and 12 months. Feasibility outcomes include recruitment, retention, adherence, intervention delivery, and data completeness. Clinical outcomes include haemoglobin response, iron indices, ESA use, and safety events. patient-reported outcomes assess quality of life, symptom burden, physical function, and cognition using validated instruments. Analyses are descriptive and exploratory, focusing on feasibility parameters and outcome variability. Discussion This trial addresses key uncertainties in iron management for people receiving PD, a population under-represented in iron therapy trials. By prioritising feasibility and incorporating patient-centred, functional, and cognitive outcomes alongside biochemical and safety measures, PALADIN provides essential methodological groundwork for a definitive phase 3 trial. The pragmatic design, aligned with routine PD care, aims to minimise participant burden while maximising data relevance. Findings will inform optimal outcome selection, sample size estimation, and trial conduct, supporting the development of evidence-based iron strategies tailored to the PD population. Trial registration IRAS: 351547 ClinicalTrials.gov: NCT06884280. Registered on 23 December 2024.