Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

• Status: Completed
• Trial end date: 2017-07-30
• Target enrollment: 0
• Participant gender: All

Summary

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Brigham and Women's Hospital; George Washington University; University of Washington; Vanderbilt University
• Treatments: Spironolactone

Criteria

Inclusion Criteria:

1. Maintenance hemodialysis therapy for end-stage renal disease

2. Age 18-85 years

3. ≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date.

4. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug.

5. Ability to provide informed consent

Exclusion Criteria:

1. Serum potassium ≥6.5 mEq/L within the 3 months prior to screening

2. Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.

3. Unscheduled dialysis for hyperkalemia within the 3 months prior to screening

4. Pre-dialysis systolic blood pressure <100 mm Hg within 2 weeks prior to screening or at the baseline visit

5. 2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure <80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension

6. Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)

7. Current use of digoxin

8. Current use of spironolactone or eplerenone

9. Allergy to spironolactone

10. Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction

11. Mitral valve repair or replacement

12. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging

13. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months

14. Expected survival <9 months

15. Pregnancy, anticipated pregnancy, or breastfeeding

16. Incarceration

17. Participation in another intervention study