High- versus low-dose iron treatment for adults on peritoneal dialysis (PALaDIN)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults on peritoneal dialysis who meet laboratory criteria for iron deficiency are enrolled and assigned to different iron dosing strategies using iron isomaltoside (Monofer) or ferrous sulfate according to the protocol. Key eligibility includes age ≥18, ferritin <700 µg/L, transferrin saturation <40%, no recent IV iron, and at least four weeks on maintenance peritoneal dialysis. The study collects blood iron indices, haemoglobin, treatment tolerability, and completion rates over follow-up to determine which dosing approach gives the clearest, most patient-relevant benefit. Safety monitoring includes liver enzymes and exclusion criteria such as haemochromatosis, recent HIF-PHI use, or anticipated need for transfusion or major surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• Hull University Teaching Hospitals NHS Trust
  Hull, East Riding Of Yorkshire, United Kingdom Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.