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Proactive High Dose Versus Low-Dose Reactive Intravenous Or Oral Iron In People On Peritoneal Dialysis PALaDIN - An Open-Label, Feasibility Randomised Study
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Actively Recruiting
Phase 3
Age: 18 Years +
All Genders
ID: 06884280
Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis
PALaDIN - an Open-label, Feasibility Randomised Study
Led by: Hull University Teaching Hospitals NHS Trust
Updated on: 2026-05-06
30 Participants Needed
1 Research Site
Total Duration
On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- How is the study designed?
- Frequently Asked Questions
- Sponsors
AI-Summary
What This Trial Is About
Chronic kidney disease is a common condition affecting many adults, with some progressing to end-stage kidney disease requiring dialysis. This trial focuses on people undergoing peritoneal dialysis, a treatment that filters toxins by exchanging fluid in the abdomen. The study aims to evaluate the impact of different iron treatments on anaemia, a frequent complication in kidney disease due to reduced red blood cell production, by assessing which measurement best reflects meaningful changes for patients and caregivers. The study is a randomized, open-label, phase 3 feasibility trial. Participants will be randomly assigned to one of three groups oral iron tablets Ferrous Sulfate 200mg daily, low-dose intravenous iron Monofer administered reactively up to every 3 months if ferritin 100 ug/L and TSAT 20, or high-dose intravenous iron Monofer administered proactively up to every 3 months if ferritin 700 ug/L and TSAT 40. The intravenous iron dose depends on blood iron markers and body weight. The study will last for 12 months, during which the effects of these treatments on anaemia and other health measures will be monitored. During the trial, researchers will track participants' anaemia response, kidney symptoms, quality of life, physical ability through a six-minute walk test, and cognitive function. They will also monitor blood transfusion frequency, need for rescue intravenous iron in the oral group, and changes in erythropoietin-stimulating agent dosages. Safety outcomes like infections and hospital admissions will be recorded. The trial includes regular assessments, symptom questionnaires, and treatment adherence checks, with follow-up lasting the full 12 months from enrollment.
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CONDITIONS
Brief Title
Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
Who Can Participate
Age: 18 Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Males and females aged ≥18 years
- Able to give informed consent
- Serum ferritin less than 700 ug/L
- Transferrin saturation level less than 40%
- No intravenous iron in the last 4 weeks before randomisation
- Received maintenance peritoneal dialysis therapy for at least 4 weeks
- Expected to remain on peritoneal dialysis therapy for duration of study
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You will not qualify if you...
- Inadequate dialysis as judged by responsible clinician
- Likely need for blood transfusion within 1 week of enrolment
- Taking or received HIF-PHI drugs in past 4 weeks
- Planned major surgery expected to affect treatment response
- Diagnosis of haemochromatosis, haemosiderosis, or ALT more than 3 times normal
- Receiving best-supportive or end-of-life care at screening
- Women of childbearing potential not using effective contraception
- Participation in another medicinal study within past 4 weeks
- Known allergy or adverse reaction to oral or intravenous iron
- C-reactive protein above 50, transferrin saturation above 40%, or serum ferritin above 700 at recruitment
- Active infection, HIV, active hepatitis B or C
- Unable or unwilling to consent or complete study procedures
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On this page
- AI-Summary
- Brief Title
- Who Can Participate
- AI-Screening
- Your Study Journey
- Trial Site Locations
- How is the study designed?
- Frequently Asked Questions
- Sponsors
Sponsors
- Hull University Teaching Hospitals NHS Trust
- Lead Sponsor
- Pharmacosmos Therapeutics, Inc.
- Collaborating Sponsor
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