Early access
Sign in
Taking peoplePhase 3

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

Key facts

Who runs it
Hull University Teaching Hospitals NHS Trust
Where
United Kingdom1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
Phase
Phase 3
People taking part
30 people, planned
Started
13 Nov 2025
Expected to end
Oct 2027
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Monofer (iron isomaltoside 1000)
  • Ferrous Sulfate
Record updated
6 May 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 19 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • On or received a HIF-PHI in the past 4 weeks
  • Anticipated major surgery that the responsible clinician feels will impact response to treatment
  • Known allergy or adverse reaction to oral or intravenous iron preparations
  • Active infection, HIV, active Hep B or C
  • Haemochromatosis / haemosiderosis or ALT >x3 normal
  • Inadequate dialysis deemed by responsible clinician
  • Probability of need for transfusion within 1 week of enrolment
  • 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
  • CRP >50, TSATs >40%, SF >700 at time of recruitment
  • Are unable or unwilling to consent to or complete the study procedures

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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).

The 3 groups in the trial

  • OralExisting treatment, for comparison

    Ferrous Sulphate 200mg once daily (oral)

    Treatment: Ferrous Sulfate

  • Reactive IntravenousTreatment being tested

    IV Monofer up to every 3 months. Administered if ferritin \<100 ug/L and TSAT \<20%

    Treatment: Monofer (iron isomaltoside 1000)

  • Proactive IntravenousTreatment being tested

    IV Monofer up to every 3 months. Administered if ferritin \<700 ug/L and TSAT \<40%

    Treatment: Monofer (iron isomaltoside 1000)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Record updated
6 May 2026