Status:
NOT_YET_RECRUITING
Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
Lead Sponsor:
Hull University Teaching Hospitals NHS Trust
Collaborating Sponsors:
Pharmacosmos Therapeutics, Inc.
Conditions:
Peritoneal Dialysis
Anaemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 freq...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06884280
Start Date
October 1 2025
End Date
October 1 2027
Last Update
March 19 2025
Active Locations (1)
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1
Hull University Teaching Hospitals NHS Trust
Hull, East Riding Of Yorkshire, United Kingdom, HU3 2JZ