Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study

NCT ID: NCT06884280

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2027-10-31

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).

Conditions

Peritoneal Dialysis; Anaemia; Iron Deficiency, Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral

Ferrous Sulphate 200mg once daily (oral)

Group Type: ACTIVE_COMPARATOR

Ferrous Sulfate

Intervention Type: DRUG

Oral iron tablet taken once daily for duration of study.

Reactive Intravenous

IV Monofer up to every 3 months. Administered if ferritin \<100 ug/L and TSAT \<20%

Group Type: EXPERIMENTAL

Monofer (iron isomaltoside 1000)

Intervention Type: DRUG

Intravenous iron infusion, administered in this study up to every 3 months. Dosage determined by haemoglobin and weight.

Proactive Intravenous

IV Monofer up to every 3 months. Administered if ferritin \<700 ug/L and TSAT \<40%

Group Type: EXPERIMENTAL

Monofer (iron isomaltoside 1000)

Intervention Type: DRUG

Intravenous iron infusion, administered in this study up to every 3 months. Dosage determined by haemoglobin and weight.

Interventions

Monofer (iron isomaltoside 1000)

Intravenous iron infusion, administered in this study up to every 3 months. Dosage determined by haemoglobin and weight.

Intervention Type: DRUG

Ferrous Sulfate

Oral iron tablet taken once daily for duration of study.

Intervention Type: DRUG

Other Intervention Names

Ferric derisomaltose

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pharmacosmos Therapeutics, Inc.

UNKNOWN

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, United Kingdom

Countries

United Kingdom

Facility Contacts

Sebastian Spencer

Role: primary

sebastian.spencer2@nhs.net

+44 01482 675093

Other Identifiers

R4171

Identifier Type: -

Identifier Source: org_study_id