Status:
COMPLETED
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Brigham and Women's Hospital
George Washington University
Conditions:
End-Stage Renal Disease
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief 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.
Detailed Description
The primary objective of this study is to characterize the safety and tolerability of multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis patients and to assess the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2017
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT02285920
Start Date
November 1 2014
End Date
July 30 2017
Last Update
July 23 2019
Active Locations (4)
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1
The George Washington University
Washington D.C., District of Columbia, United States, 20037
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02120
3
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
4
Kidney Research Institute, University of Washington
Seattle, Washington, United States, 98104