L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD

NCT01855334 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2017-05-04

No results posted yet for this study

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

Interventions

DRUG

Spironolactone

DIETARY_SUPPLEMENT

L-arginine

DRUG

Placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01855334 on ClinicalTrials.gov