Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2025-12-25 @ 2:51 AM
NCT ID:
NCT03857633
Eligibility Criteria:
Inclusion Criteria:
1. Patients with a diagnosis of Chronic Kidney Disease stage 4 and above
2. Patients with a progressive decline in renal function with a expectation to require future renal replacement therapy or currently on renal replacement therapy (Haemodialysis or Peritoneal Dialysis)
3. Exclusion of macrovascular cardiac disease within the last 3 years
4. Access for haemodialysis planned via tunnelled central venous catheter
Exclusion Criteria:
1. Age under eighteen
2. Patients with a diagnosis of Diabetes Mellitus
3. Untreated macrovascular cardiac disease or Acute Coronary syndrome within 6 months of recruitment
4. Previous or current treatment with immunosuppressive/modulatory therapy
5. Current Malignancy
6. Current use of Metformin
7. Pregnancy
8. Contraindication to MRI Imaging
9. Patients lacking capacity or unable to consent and non-English language speakers
10. Immediate modality switch after commencement on renal replacement therapy i.e. transplantation
11. Plan for treatment centre change/move outside of Imperial College Healthcare NHS Trust following commencement on renal replacement therapy
12. Patients currently participating in an active CTIMP trial
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03857633
Study Brief:
Protocol Section:
NCT03857633