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NCT06884280 | NOT YET RECRUITING | Peritoneal Dialysis

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

Hull University Teaching Hospitals NHS Trust

Brief Summary:

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).

Condition or disease

Peritoneal Dialysis

Anaemia

Iron Deficiency, Anaemia

Intervention/treatment

Monofer (iron isomaltoside 1000)

Ferrous Sulfate

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study
Actual Study Start Date : 2025-10
Estimated Primary Completion Date : 2027-10
Estimated Study Completion Date : 2027-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
  • * 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
Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

Location Details

NCT06884280

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How to Participate

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Locations

Not yet recruiting

United Kingdom, East Riding Of Yorkshire

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ