PALaDIN Study: High vs. Low Dose Iron in Peritoneal Dialysis PatientsCan high-dose iron improve health for people on peritoneal dialysis?

Status: RECRUITING | Phase: PHASE3 Condition(s): Peritoneal Dialysis, Anaemia, Iron Deficiency, Anaemia Intervention(s): Monofer (iron isomaltoside 1000) (DRUG), Ferrous Sulfate (DRUG) Chronic kidney disease affects a significant portion of the UK population, with approximately 3.5 million adults diagnosed. At its most severe stage, end-stage kidney disease, individuals require frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body. The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial. In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production). Primary Outcome(s): Eligibility to consent rate (%); Recruitment rate (%); Participant retention to 12 month follow-up (%) Enrollment: 30 (ESTIMATED) Lead Sponsor: Hull University Teaching Hospitals NHS Trust Start: 2025-11-13 | Primary Completion: 2027-10