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

NHS Trust

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Peritoneal Dialysis; Iron Deficiency, Anaemia; Anaemia

Treatments: Drug: Monofer (iron isomaltoside 1000); Drug: Ferrous Sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06884280

R4171

Details and patient eligibility

About

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).

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Oral

Active Comparator group

Description:

Ferrous Sulphate 200mg once daily (oral)

Treatment:

Drug: Ferrous Sulfate

Reactive Intravenous

Experimental group

Description:

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

Treatment:

Drug: Monofer (iron isomaltoside 1000)

Proactive Intravenous

Experimental group

Description:

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

Treatment:

Drug: Monofer (iron isomaltoside 1000)