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

Completed · Phase 2 · Has a placebo group

Conditions studied: End-Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02285920

Run by

University of Pennsylvania

People needed

129

Starts

2014-11-01

Expected to finish

2017-07-30

Last updated by the study team

2019-07-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The George Washington University — Washington D.C., District of Columbia, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Kidney Research Institute, University of Washington — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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