CompletedPhase 2

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

United States129 participantsStarted 2014-11

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety - Number of Participants With Serum Potassium >6.5 mEq/L

Timeframe: 0 - 40 weeks

Safety - Participants With Serious Hypotension

Timeframe: 0 - 40 weeks

Study Drug Tolerability

Timeframe: 0 - 36 weeks

Efficacy - Change in Mitral Annular E' Velocity

Timeframe: Baseline to 36 weeks

Feasibility of Conducting a Full-scale Mortality-powered Trial

Timeframe: 0 - 40 weeks

Trial details

NCT IDNCT02285920

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

Results submitted2019-02-19

View on ClinicalTrials.gov More End-Stage Renal Disease trials

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Safety - Number of Participants With Serum Potassium >6.5 mEq/L

Timeframe: 0 - 40 weeks

Safety - Participants With Serious Hypotension

Timeframe: 0 - 40 weeks

Study Drug Tolerability

Timeframe: 0 - 36 weeks

Efficacy - Change in Mitral Annular E' Velocity

Timeframe: Baseline to 36 weeks

Feasibility of Conducting a Full-scale Mortality-powered Trial

Timeframe: 0 - 40 weeks