Health Condition 1: N186- End stage renal disease
Conditions
Interventions
Intervention1: Spironolactone: 25mg of the active drug as tablet formulation will be administered once daily till an outcome or adverse event occurs during the entire duration of the trial.
Control In
Sponsors
Population Health Research Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age >=18 with a history of diabetes 2. On dialysis >= 90 days 3. On either a. Hemodialysis prescribed at least 2 treatments per week or b. Peritoneal dialysis prescribed with at least 1 exchange daily 4. Provides informed consent
Exclusion criteria
Exclusion criteria: 1. Hyperkalemia a. Serum potassium >5.8 mmol/L in the 6 weeks prior to enrollment or b. 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 7. Enrolled in another interventional trial testing a mineralocorticoid receptor antagonist or drug that has a known or likely interaction with spironolactone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of cardiac death or hospitalization for heart failureTimepoint: Months 3, 6, 12, 18, 24, 30, 36,42,48,54, 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Cause specific death (cardiac, other vascular, non-vascular) 2 Hospitalization for heart failure 3 All-cause death 4 All-cause hospitalizations 5 Hospitalization for hyperkalemia Timepoint: Months 3, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 | — |
Countries
Argentina, Australia, Brazil, Canada, China, Colombia, Czech Republic, Ecuador, India, Malaysia, New Zealand, Philippines, Poland, Turkey, United Kingdom, Uruguay
Contacts
Public ContactDr Atiya Faruqui
St. Johns Research Institute St. Johns National Academy of Health Sciences
Outcome results
None listed