At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Monofer (iron isomaltoside 1000) (drug), Ferrous Sulfate (drug)
- How long the study runs
- Study runs about 23 months (dates as stated)
- About the drug or intervention
- Monofer (iron isomaltoside 1000) — drug: Intravenous iron infusion, administered in this study up to every 3 months. · Ferrous Sulfate — drug: Oral iron tablet taken once daily for duration of study.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 30
- Started
- 2025-11-13
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for peritoneal dialysis
- • Phase3 - 30 participants
- • Chronic kidney disease affects a significant portion of the UK population, with approximately 3
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with peritoneal dialysis
Where?
- • Hull - Hull University Teaching Hospitals NHS Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
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).
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Males and females aged ≥18 years.
- ✓Able to give agreement to take part
- ✓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...
Who cannot take part
- ✗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 liver enzymes \>x3 normal
See the full criteria
Where Is This Study? (1 UK site)
Hull University Teaching Hospitals NHS Trust
Hull HU3 2JZ, United Kingdom