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:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT03020303
Eligibility Criteria:
Inclusion Criteria:
1. Age
1. ≥45 years or
2. ≥18 with a history of diabetes
2. On dialysis ≥ 90 days
3. On either
1. Hemodialysis prescribed at least 2 treatments per week or
2. Peritoneal dialysis prescribed with at least 1 exchange daily
4. Provides informed consent
Exclusion Criteria:
1. Hyperkalemia
1. Serum potassium \>5.8 mmol/L in the 6 weeks prior to enrollment or
2. Serum potassium \>6.0 mmol/L during active run-in
2. Currently taking and unable to withdraw a mineralocorticoid receptor antagonist (i.e. spironolactone or eplerenone).
3. Known sensitivity or allergy to spironolactone
4. Current or planned pregnancy or breastfeeding
5. Scheduled living related donor renal transplant
6. Life expectancy \< 6 months in the opinion of a treating nephrologist.
7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
8. Treating physician believes either spironolactone is either absolutely indicated or absolutely contra-indicated
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03020303
Study Brief:
Protocol Section:
NCT03020303