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

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