Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
Launched by HULL UNIVERSITY TEACHING HOSPITALS NHS TRUST · Mar 17, 2025
Trial Information
Current as of May 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
The PALaDIN Study is a clinical trial designed to compare the effects of high-dose and low-dose iron treatments on people with chronic kidney disease who are undergoing peritoneal dialysis. This study is important because many patients with kidney disease experience anemia, which means they have fewer red blood cells and can feel tired and weak. Participants in the trial will be randomly assigned to receive either high-dose intravenous iron, low-dose intravenous iron, or oral iron supplements. Over the course of a year, researchers will monitor how well these treatments help improve anemia, the participants' quality of life, how well they can perform physical activities, and their mental function.
To be eligible for the trial, participants must be 18 years or older, able to give informed consent, and have specific blood test results indicating iron deficiency. They should have been on peritoneal dialysis for at least four weeks and are expected to continue this treatment throughout the study. Participants will not be eligible if they have certain health conditions or are currently receiving other treatments that might interfere with the study. This trial aims to determine which iron treatment works best for patients with kidney disease and anemia, ultimately helping to improve their health and well-being.
Gender
ALL
Eligibility 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
- • 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
About Hull University Teaching Hospitals Nhs Trust
Hull University Teaching Hospitals NHS Trust is a leading healthcare organization dedicated to delivering high-quality patient care, education, and research. Located in Hull, England, the Trust encompasses a range of hospitals and healthcare services, providing a comprehensive spectrum of clinical specialties. With a strong commitment to advancing medical science, the Trust actively sponsors and conducts clinical trials that aim to improve patient outcomes and contribute to evidence-based practice. By collaborating with academic partners and leveraging its state-of-the-art facilities, Hull University Teaching Hospitals NHS Trust fosters an innovative research environment that prioritizes patient safety and ethical standards.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hull, East Riding Of Yorkshire, United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported