End-Stage Renal Disease Clinical Trial
— SPin-DOfficial title:
Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial
NCT number | NCT02285920 |
Other study ID # | 821193 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | July 30, 2017 |
Verified date | July 2019 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 129 |
Est. completion date | July 30, 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
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 | The George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | Brigham and Women's Hospital, George Washington University, University of Washington, Vanderbilt University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety - Number of Participants With Serum Potassium >6.5 mEq/L | The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm. | 0 - 40 weeks | |
Primary | Safety - Participants With Serious Hypotension | The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection). | 0 - 40 weeks | |
Primary | Study Drug Tolerability | Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction. | 0 - 36 weeks | |
Primary | Efficacy - Change in Mitral Annular E' Velocity | Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy. | Baseline to 36 weeks | |
Primary | Feasibility of Conducting a Full-scale Mortality-powered Trial | An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates. | 0 - 40 weeks | |
Secondary | Safety - Number of Participants With Serious Hyperkalemia | Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy | 0 - 40 weeks | |
Secondary | Safety - Hyperkalemia Requiring Adjustment in Treatment | Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication | 0 - 40 weeks | |
Secondary | Safety - Inter- or Intra-dialytic Hypotension | Inter- or intra-dialytic hypotension defined as: Inter-dialytic: systolic blood pressure <90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room. Intra-dialytic: systolic blood pressure <80 mm Hg during =3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during =3 dialysis sessions per 30-day period |
0 - 40 weeks | |
Secondary | Safety - Cardiovascular Death | Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease | 0 - 40 weeks | |
Secondary | Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function • Change in left ventricular ejection fraction between Baseline and 36 weeks |
Baseline - 36 weeks | |
Secondary | Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in left ventricular mass index (LVMI) between baseline and 36 weeks |
Baseline - 36 weeks | |
Secondary | Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E') | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E') |
Baseline - 36 weeks | |
Secondary | Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS) | Secondary outcome measures include other echocardiographic markers of systolic and diastolic function, • Change in myocardial strain and strain rate between baseline and 36 weeks |
Baseline - 36 weeks | |
Secondary | Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia | The number of participants who had serum potassium >6.5 mEq/L or serious hyperkalemia was assessed by treatment arm. | 0 - 40 Weeks |
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