Nephrology
PHASE3
● Phase III
PALaDIN Study: High vs. Low Dose Iron in Peritoneal Dialysis Patients
ClinicalTrials.gov
Published March 28, 2026
Hull University Teaching Hospitals NHS Trust
NCT06884280 ↗
The PALaDIN study is a phase 3 clinical trial currently recruiting participants to evaluate the effectiveness of high-dose versus low-dose intravenous iron treatments, as well as oral iron therapy, in individuals undergoing peritoneal dialysis. This trial targets patients with chronic kidney disease who experience anaemia, a common complication due to kidney failure. The study will involve 30 participants who will be randomly assigned to one of the treatment groups. Over a 12-month period, the trial will assess various outcomes including anaemia response, symptoms of kidney disease, quality of life, physical performance, cognitive function, and the need for blood transfusions. Additionally, the study will monitor whether participants on oral iron require intravenous iron and any changes in erythropoietin-stimulating agent dosages. Primary outcomes include the eligibility to consent rate, recruitment rate, and participant retention to the 12-month follow-up. The trial is sponsored by Hull University Teaching Hospitals NHS Trust and is set to start on November 13, 2025, with primary completion expected by October 2027.
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Chronic kidney disease is a serious issue, impacting about 3.5 million adults in the UK. For those with end-stage kidney disease, peritoneal dialysis is a lifeline, but it often comes with the challenge of anemia. This trial aims to find out if high-dose intravenous iron is more effective than low-dose iron or oral iron for improving health in these patients. Over a year, participants will be monitored for their anemia response, symptoms of kidney disease, quality of life, and even how well they can walk. The study will also look at how often blood transfusions are needed and whether oral iron users require intravenous iron. By understanding these factors, the trial hopes to identify the best treatment options for those undergoing peritoneal dialysis, ultimately aiming to enhance their overall well-being.
What this means for you: This trial will explore the best iron treatment to improve life for those on peritoneal dialysis.
View Original Abstract ↓
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
