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).
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Eligibility to consent rate (%)
Timeframe: From enrollment to the end of treatment at 12 months
Recruitment rate (%)
Timeframe: From enrollment to the end of treatment at 12 months
Participant retention to 12 month follow-up (%)
Timeframe: From enrollment to the end of treatment at 12 months
Completion of clinical outcomes at follow-up and patterns of missing data for the study measures (%)
Timeframe: From enrollment to the end of treatment at 12 months
Completion of patient symptom questionnaires throughout the study (%)
Timeframe: From enrollment to the end of treatment at 12 months
Treatment adherence (%)
Timeframe: From enrollment to the end of treatment at 12 months
Treatment fidelty (%)
Timeframe: From enrollment to the end of treatment at 12 months
Treatment acceptability (%)
Timeframe: From enrollment to the end of treatment at 12 months