High- versus low-dose iron treatment for adults on peritoneal dialysis (PALaDIN)
Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study
This project will see if higher-dose versus lower-dose iron treatment helps adults on peritoneal dialysis with iron-deficiency anaemia keep their iron and haemoglobin levels more stable.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hull University Teaching Hospitals NHS Trust Government |
| Locations | 1 site (Hull, East Riding Of Yorkshire) |
| Trial ID | NCT06884280 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults on maintenance peritoneal dialysis with iron deficiency (ferritin <700 µg/L and transferrin saturation <40%), not recently given IV iron and expected to remain on peritoneal dialysis for the study duration.
Not a fit: Patients with haemochromatosis or marked liver enzyme elevation, those likely to need imminent transfusion or currently receiving end-of-life care, women of childbearing potential not using effective contraception, or those unable to attend the Hull site are unlikely to receive benefit or are excluded.
Why it matters
Potential benefit: If successful, this could identify an optimal iron dosing approach to improve anaemia control and reduce complications and treatment burden for people on peritoneal dialysis.
How similar studies have performed: Intravenous iron has shown benefit for anaemia management in dialysis populations, especially haemodialysis, but the best dosing strategy for peritoneal dialysis patients is less well established.
Eligibility criteria
Show full inclusion / exclusion 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 * 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 this trial is running
Hull, East Riding Of Yorkshire
- Hull University Teaching Hospitals NHS Trust — Hull, East Riding Of Yorkshire, United Kingdom (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.