Chronic Kidney Disease Clinical Trials

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Proactive High Dose Versus Low-dose Reactive Intravenous or Oral Iron in People on Peritoneal Dialysis (PALaDIN) - an Open-label, Feasibility Randomised Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
Time Frame
Start Date: 2025-11-13
Estimated Completion Date: 2027-10
Participants
Target number of participants: 30
Treatments
Active_comparator: Oral
Ferrous Sulphate 200mg once daily (oral)
Experimental: Reactive Intravenous
IV Monofer up to every 3 months. Administered if ferritin \<100 ug/L and TSAT \<20%
Experimental: Proactive Intravenous
IV Monofer up to every 3 months. Administered if ferritin \<700 ug/L and TSAT \<40%
Related Therapeutic Areas
Sponsors
Leads: Hull University Teaching Hospitals NHS Trust
Collaborators: Pharmacosmos Therapeutics, Inc.

This content was sourced from clinicaltrials.gov