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Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

RecruitingPhase 3Ages 18 Years - anyAllHull University Teaching Hospitals NHS Trust
NCT06884280 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 v

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📋 Eligibility rules (as published)
Inclusion Criteria: * Males and females aged ≥18 years. * Able to give informed consent * Serum ferritin \<700ug/L * Transferrin saturation level \<40% * No intravenous iron for last 4 weeks before randomisation (patients may be pre-identified and included after 4-week washout period) * Received maintenance peritoneal dialysis therapy for at least 4 weeks * Expected to remain on peritoneal dialysis therapy for duration of study Exclusion Criteria: * Inadequate dialysis deemed by responsible clinician * Probability of need for transfusion within 1 week of enrolment * On or received a HIF-PHI in the past 4 weeks * Anticipated major surgery that the responsible clinician feels will impact response to treatment * Haemochromatosis / haemosiderosis or ALT \>x3 normal * Are deemed to be most suited to best-supportive or end-of-life care at time of screening * Women of childbearing potential not using effective means of contraception * Have been involved in another medicinal study (CTIMP) within past 4 weeks * Known allergy or adverse reaction to oral or intravenous iron preparations * CRP \>50, TSATs \>40%, SF \>700 at time of recruitment * Active infection, HIV, active Hep B or C * Are unable or unwilling to consent to or complete the study procedures
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What it tests

  • Monofer (iron isomaltoside 1000)
  • Ferrous Sulfate
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Where

1 site
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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