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Compares treatment options for Peritoneal Dialysis
Official title Comparing High and Low Dose Iron Treatments for People on Peritoneal Dialysis: The PALaDIN Study
ClinicalTrials.gov ID: NCT06884280
What this study is testing
What is Monofer (iron isomaltoside 1000)?
Monofer (iron isomaltoside 1000) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for peritoneal dialysis.
Also referred to as Ferric derisomaltose.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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)
You likely can't join 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Hull, East Riding Of Yorkshire, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hull, East Riding Of Yorkshire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.