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

NCT06884280 | Recruiting Phase 3

• 1 other identifier: R4171
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• Eligibility to consent rate (%)

  This refers to the proportion of participants who are eligible for the study and who provide informed consent to participate. Measuring Eligibility to Consent Eligibility-to-Consent Rate: (Number of eligible participants who consented / Total number of eligible participants) × 100% A low eligibility-to-consent ratio may suggest challenges in participant engagement, while a high ratio indicates good participant willingness to take part.

  From enrollment to the end of treatment at 12 months

• Recruitment rate (%)

  The recruitment rate refers to the speed at which participants are enrolled into a study over a given time period. Measuring Recruitment Rate Recruitment Rate: (Number of participants enrolled / Time period, e.g., per month) For multi-site studies, it can be adjusted per site: Recruitment Rate per Site: (Total participants enrolled / Number of sites × Time period) A high recruitment rate suggests effective recruitment strategies, while a low rate may highlight recruitment barriers.

  From enrollment to the end of treatment at 12 months

• Participant retention to 12 month follow-up (%)

  Participant retention refers to the proportion of participants who remain in the study and complete follow-up assessments over time. Measuring Retention Retention Rate at Follow-Up: (Number of participants completing follow-up assessments / Total participants enrolled) × 100% A high retention rate reflects good participant engagement, while a low rate may suggest challenges such as participant burden or study fatigue.

  From enrollment to the end of treatment at 12 months

• Completion of clinical outcomes at follow-up and patterns of missing data for the study measures (%)

  This refers to the proportion of participants who complete the clinical outcomes measures at follow-up. Measuring Completion of Clinical Outcomes Completion Rate of Clinical Outcomes: (Number of participants with complete clinical outcome data / Total participants expected at follow-up) × 100% This measures how well the study is able to collect necessary data, with a high completion rate indicating effective data collection processes.

  From enrollment to the end of treatment at 12 months

• Completion of patient symptom questionnaires throughout the study (%)

  This refers to the proportion of scheduled symptom questionnaires that participants complete during the study. It is an important measure of participant engagement and the completeness of patient-reported outcome data. Measuring Completion of Patient Symptom Questionnaires Questionnaire Completion Rate: (Number of completed questionnaires / Total number of expected questionnaires) × 100% A high completion rate indicates good participant involvement and reliable data, while a low rate may suggest that the questionnaires are burdensome, inconvenient, or not seen as valuable by participants.

  From enrollment to the end of treatment at 12 months

• Treatment adherence (%)

  Treatment adherence refers to how well participants follow the prescribed treatment regimen, whether it is medication, lifestyle changes, or other interventions. Measuring Adherence Adherence Rate: (Number of prescribed doses/sessions completed / Total prescribed doses/sessions) × 100% A high adherence rate indicates good compliance, while a low rate may indicate barriers such as treatment side effects, participant preference, or complexity of the regimen.

  From enrollment to the end of treatment at 12 months

• Treatment fidelty (%)

  Treatment fidelity refers to the degree to which the intervention is delivered as per the study protocol, ensuring consistency across all participants and study sites. Measuring Fidelity Fidelity Rate: (Number of intervention components delivered as intended / Total expected intervention components) × 100% A high fidelity rate suggests that the intervention is being delivered consistently as intended, while a low rate may indicate deviations in protocol delivery.

  From enrollment to the end of treatment at 12 months

• Treatment acceptability (%)

  Treatment acceptability refers to how acceptable participants or healthcare providers find the study intervention, including factors such as ease of use, side effects, and perceived effectiveness. Measuring Acceptability Acceptability Rate: (Number of participants rating treatment as acceptable / Total participants assessed) × 100% Acceptability is often measured through surveys or questionnaires, and a high rate indicates that participants find the treatment tolerable and beneficial. Low acceptability may highlight barriers such as side effects or perceived inefficacy.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (20)

• Adverse and serious adverse events

  From enrollment to the end of treatment at 12 months

• Mortality and Major Adverse Cardiovascular Events (MACE)

  From enrollment to the end of treatment at 12 months

• Hospital Admissions

  From enrollment to the end of treatment at 12 months

• Drug Reactions

  From enrollment to the end of treatment at 12 months

• Infections and Peritoneal Dialysis Peritonitis

  From enrollment to the end of treatment at 12 months

Study Arms (3)

Oral

ACTIVE COMPARATOR

Ferrous Sulphate 200mg once daily (oral)

Drug: Ferrous Sulfate

Reactive Intravenous

EXPERIMENTAL

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

Drug: Monofer (iron isomaltoside 1000)

Proactive Intravenous

EXPERIMENTAL

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

Drug: Monofer (iron isomaltoside 1000)

Interventions

Monofer (iron isomaltoside 1000) DRUG

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

Also known as: Ferric derisomaltose

Proactive Intravenous; Reactive Intravenous

Ferrous Sulfate DRUG

Oral iron tablet taken once daily for duration of study.

Oral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inadequate dialysis deemed by responsible clinician
• Probability of need for transfusion within 1 week of enrolment
• On or received a HIF-PHI in the past 4 weeks
• 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

Sponsors & Collaborators

• Pharmacosmos Therapeutics, Inc.: collaborator
• Hull University Teaching Hospitals NHS Trust: lead

Study Sites (1)

Hull University Teaching Hospitals NHS Trust

Hull, East Riding Of Yorkshire, HU3 2JZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Anemia; Anemia, Iron-Deficiency

Interventions

iron isomaltoside 1000; ferric derisomaltose; ferrous sulfate

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Anemia, Hypochromic; Iron Deficiencies; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: March 19, 2025
• Study Start: November 13, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)