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

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: End-Stage Renal Disease

Intervention: Spironolactone (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Laura M Dember, MD, Principal Investigator, Affiliation: University of Pennsylvania

Overall contact:
Denise Cifelli, MS, Phone: 2155734534, Email: cifelli@upenn.edu

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.

Clinical Details

Official title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Safety

Safety

Tolerability

Efficacy

Feasibility

Secondary outcome:

Safety

Efficacy

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 feasibility of conducting a full-scale, mortality-powered trial of SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters will also be analyzed. The primary efficacy parameter will be the change in the E' measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be studied in the overall population or in sub-studies include heart rate variability, circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular function. These parameters are designed to broaden insight into the potential effects of SPL on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess the feasibility of conducting a full-scale, mortality-powered trial.

Eligibility

Minimum age: 18 Years. Maximum age: 85 Years. Gender(s): Both.

Criteria:

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 intra-dialytic 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. Use of non-selective beta blockers (propanolol, labetalol, carvedilol) 8. Current use of digoxin 9. Current use of spironolactone or epleronone 10. Allergy to spironolactone 11. 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 12. Mitral valve repair or replacement 13. Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging 14. Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months 15. Expected survival <9 months 16. Pregnancy, anticipated pregnancy, or breastfeeding 17. Incarceration 18. Participation in another intervention study

Locations and Contacts

Denise Cifelli, MS, Phone: 2155734534, Email: cifelli@upenn.edu

The George Washington University, Washington, District of Columbia 20037, United States; Recruiting
Maria Wing, PhD, Email: mwing@mfa.gwu.edu
Dominic S Raj, MD, Principal Investigator

Brigham and Women's Hospital, Boston, Massachusetts 02120, United States; Recruiting
Angeles Cinelli, BA, Phone: 617-525-9436, Email: mcinelli@partners.org
David Charytan, MD, Principal Investigator

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States; Recruiting
Cindy Booker, LPN, Phone: 615-343-5828, Email: cindy.a.booker@vanderbilt.edu
Alp Ikizler, MD, Principal Investigator

Kidney Research Institute, University of Washington, Seattle, Washington 98104, United States; Recruiting
Lori Linke, BA, Phone: 206-720-3835, Email: lori.linke@nwkidney.org
Jonathan Himmelfarb, MD, Principal Investigator

Additional Information

Starting date: November 2014
Last updated: August 6, 2015

Page last updated: August 23, 2015

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