Phase 2
Completed N=129
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
Source: ClinicalTrials.gov NCT02285920 ↗Enrolled (actual)
129
Serious AEs
50.4%
Results posted
Jul 2019
Primary outcomePrimary: Safety - Number of Participants With Serum Potassium >6.5 mEq/L — 9; 4; 4; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety - Number of Participants With Serum Potassium >6.5 mEq/L |
9; 4; 4; 8 | — |
| PRIMARY Safety - Participants With Serious Hypotension |
0; 2; 0; 3 | — |
| PRIMARY Study Drug Tolerability |
16; 5; 6; 8 | — |
| PRIMARY Efficacy - Change in Mitral Annular E' Velocity |
7.4; 7.6; 7.8; 7.0; 7.5; 7.4 | — |
| PRIMARY Feasibility of Conducting a Full-scale Mortality-powered Trial |
2; 2; 2; 0; 0; 0 | — |
| SECONDARY Safety - Number of Participants With Serious Hyperkalemia |
6; 2; 0; 7 | — |
| SECONDARY Safety - Hyperkalemia Requiring Adjustment in Treatment |
13; 2; 5; 7 | — |
| SECONDARY Safety - Inter- or Intra-dialytic Hypotension |
3; 1; 1; 0; 20; 9 | — |
| SECONDARY Safety - Cardiovascular Death |
1; 0; 2; 1 | — |
| SECONDARY Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF) |
68.9; 65.9; 66.0; 68.2; 70.7; 66.9 | — |
| SECONDARY Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI) |
105.2; 115.5; 116.4; 106.3; 94.8; 104.6 | — |
| SECONDARY Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E') |
10.7; 11.8; 9.2; 12.5; 11.5; 12.2 | — |
| SECONDARY Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS) |
-17.2; -16.7; -17.2; -17.4; -18.1; -17.0 | — |
| SECONDARY Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia |
13; 5; 5; 10 | — |
Eligibility Criteria
Inclusion Criteria
- Maintenance hemodialysis therapy for end-stage renal disease
- Age 18-85 years
- ≥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.
- 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.
- Ability to provide informed consent
Exclusion Criteria
- Serum potassium ≥6.5 mEq/L within the 3 months prior to screening
- 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.
- Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
- Pre-dialysis systolic blood pressure <100 mm Hg within 2 weeks prior to screening or at the baseline visit
- 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
- Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)
- Current use of digoxin
- Current use of spironolactone or eplerenone
- Allergy to spironolactone
- 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
- Mitral valve repair or replacement
- Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging
- Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
- Expected survival <9 months
- Pregnancy, anticipated pregnancy, or breastfeeding
- Incarceration
- Participation in another intervention study
Data sourced from ClinicalTrials.gov (NCT02285920). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.