Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorHull University Teaching Hospitals NHS Trust
About this trial
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
This trial does not accept healthy volunteersQualifiers
Males and females aged ≥18 years.
Able to give informed consent
Serum ferritin <700ug/L
Transferrin saturation level <40%
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Monofer (iron isomaltoside 1000)
DrugIntravenous iron infusion, administered in this study up to every 3 months. Dosage determined by haemoglobin and weight.
Ferrous Sulfate
DrugOral iron tablet taken once daily for duration of study.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: OralActive comparator 1 intervention
Group B: Reactive IntravenousExperimental treatment 1 intervention
Group C: Proactive IntravenousExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 12 months2
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.
Time frame
From enrollment to the end of treatment at 12 months3
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.
Time frame
From enrollment to the end of treatment at 12 months4
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.
Time frame
From enrollment to the end of treatment at 12 monthsSecondary outcomes
1
Adverse and serious adverse events
Adverse Events (AEs) An adverse event (AE) is any unwanted or harmful medical occurrence in a participant receiving a study intervention, regardless of whether it is directly related to the intervention. This includes symptoms, abnormal lab findings, or worsening of an existing condition. Measuring AEs Incidence Rate: (Number of participants experiencing at least one AE / Total participants enrolled) × 100% AE Frequency: Total number of AEs / Total participants enrolled Severity Grading: Often classified as mild, moderate, or severe based on clinical criteria (e.g., CTCAE grading system).
Time frame
From enrollment to the end of treatment at 12 months2
Mortality and Major Adverse Cardiovascular Events (MACE)
Mortality and Major Adverse Cardiovascular Events (MACE) Mortality refers to the number of deaths occurring in the study population. Major Adverse Cardiovascular Events (MACE) typically include cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and heart failure hospitalisation. Measuring Mortality and MACE Mortality Rate: (Number of deaths / Total participants enrolled) × 100% MACE Incidence Rate: (Number of participants experiencing at least one MACE / Total participants enrolled) × 100% Event-Specific Rates: Tracking occurrences of cardiovascular death, myocardial infarction, stroke, and heart failure admissions separately.
Time frame
From enrollment to the end of treatment at 12 months3
Hospital Admissions
This includes any unplanned or planned hospitalisations occurring during the study period. It is a key measure of disease burden and healthcare utilisation. Measuring Hospital Admissions Hospital Admission Rate: (Number of participants admitted to hospital / Total participants enrolled) × 100% Admission Frequency: Total number of hospital admissions / Total participants enrolled Length of Stay: Average number of days spent in hospital per admission
Time frame
From enrollment to the end of treatment at 12 months4
Drug Reactions
This includes any adverse reactions or side effects experienced by participants due to study medication. Reactions can range from mild to severe, including life-threatening anaphylaxis or organ toxicity. Measuring Drug Reactions Incidence Rate: (Number of participants experiencing at least one drug reaction / Total participants receiving the drug) × 100% Severity Grading: Categorising reactions as mild, moderate, severe, or life-threatening Causality Assessment: Evaluating whether the reaction is likely related to the study drug
Time frame
From enrollment to the end of treatment at 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hull University Teaching Hospitals NHS Trust
Lead sponsor
Pharmacosmos Therapeutics, Inc.
Collaborator
Source ClinicalTrials.gov