L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
NCT01855334 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2017-05-04
Summary
Cardiovascular disease is the primary cause of death in patients with end stage renal disease (ESRD). New research suggests that the high risk of death may be partly due to high levels of fibrosis and a loss of small blood vessels in the heart of patients with dialysis-dependent ESRD. This study is designed to compare the effects of two different drugs, spironolactone and L-arginine, with placebo on structure and function of the heart in individuals with dialysis-dependent ESRD.
Conditions
- End Stage Renal Disease
- Hemodialysis
Interventions
- DRUG
-
Spironolactone
- DIETARY_SUPPLEMENT
-
L-arginine
- DRUG
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER -
Beth Israel Deaconess Medical Center
collaborator OTHER -
Joslin Diabetes Center
collaborator OTHER -
Brigham and Women's Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-09-30
- Primary Completion
- 2018-07-31
- Completion
- 2018-07-31
Countries
- United States
Study Locations
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