Clinical trial NCT06884280: Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
Official title: Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Peritoneal Dialysis
Anaemia
Iron Deficiency, Anaemia
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Pharmacosmos Therapeutics, Inc.
First posted: 2025-03-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 frequent dialysis treatment. One form of dialysis, known as peritoneal dialysis, involves introducing and removing fluid from the abdominal cavity to help filter out toxins from the body.

The kidneys are involved in various hormonal processes, including those responsible for producing red blood cells, making anaemia a common consequence of kidney failure. When designing a clinical trial to evaluate the effectiveness of any treatment, it is essential to determine the number of suitable and willing participants, as well as those who can complete all required tests and measurements. Identifying the most appropriate measurement to assess the impact of intravenous iron (iron injected directly into veins) is crucial to ensure that any observed changes are meaningful to people with CKD and their carers. To address these considerations, the investigators will conduct a pilot feasibility trial.

In this trial, individuals with kidney disease undergoing peritoneal dialysis will be randomly assigned to receive either high-dose or low-dose intravenous iron, or oral iron therapy. Over twelve months, the investigators will monitor their anaemia response, symptoms of kidney disease, quality of life, physical performance (such as the ability to walk for six minutes), and cognitive function. Additionally, the investigators will assess the impact of each intervention on the frequency of blood transfusions, whether those on oral iron require intravenous iron, and any changes in the dosage of erythropoietin-stimulating agents (drugs that increase blood production).


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

Primary outcomes:
measure: Eligibility to consent rate (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Recruitment rate (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Participant retention to 12 month follow-up (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Completion of clinical outcomes at follow-up and patterns of missing data for the study measures (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Completion of patient symptom questionnaires throughout the study (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Treatment adherence (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Treatment fidelty (%)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Treatment acceptability (%)
timeFrame: From enrollment to the end of treatment at 12 months
Secondary outcomes:
measure: Adverse and serious adverse events
timeFrame: From enrollment to the end of treatment at 12 months
measure: Mortality and Major Adverse Cardiovascular Events (MACE)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Hospital Admissions
timeFrame: From enrollment to the end of treatment at 12 months
measure: Drug Reactions
timeFrame: From enrollment to the end of treatment at 12 months
measure: Infections and Peritoneal Dialysis Peritonitis
timeFrame: From enrollment to the end of treatment at 12 months
measure: Quality of life (KDQoL-SF)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Symptom burden (IPOS-Renal, PROMIS Global Health Instrument)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Physical Function (6-Minute Walk Test)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Cognitive Function (MoCA)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Residual Renal Function (Creatinine Clearance)
timeFrame: From enrollment to the end of treatment at 12 months
measure: Restless Legs Syndrome (IRLSSG)
timeFrame: From enrollment to the end of treatment at 12 months
measure: >10g/L Rise in Haemoglobin (Hb)
timeFrame: From enrollment to the end of treatment at 12 months
measure: % with Haemoglobin >110g/L
timeFrame: From enrollment to the end of treatment at 12 months
measure: Ferritin >200ug/L
timeFrame: From enrollment to the end of treatment at 12 months
measure: TSAT >20%
timeFrame: From enrollment to the end of treatment at 12 months
measure: % Receiving Rescue Therapy
timeFrame: From enrollment to the end of treatment at 12 months
measure: Quality-Adjusted Life Years
timeFrame: From enrollment to the end of treatment at 12 months
measure: Change in Erythropoiesis-Stimulating Agent (ESA) Dose
timeFrame: From enrollment to the end of treatment at 12 months
measure: Cumulative Iron Dose
timeFrame: From enrollment to the end of treatment at 12 months
measure: Cost per Outcome
timeFrame: From enrollment to the end of treatment at 12 months
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: East Riding Of Yorkshire
Study officials:
References: