Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
A Multi-Center, Randomized, Controlled, Double-Blind, Phase II Study To Assess Safety and Efficacy With the Renal Assist Device (RAD) in Patients With Acute Renal Failure
1 other identifier
interventional
N/A
1 country
16
Brief Summary
- The purpose of this study is to evaluate the safety and efficacy of the RAD to determine whether the RAD is effective in reducing mortality in patients with Acute Renal Failure due to Acute Tubule Necrosis and to evaluate the safety of the RAD
- If the RAD works normally when used for as long as 72 hours
- If the RAD will provide added benefits to normal CVVH therapy for patients with Acute Renal Failure
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2006
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2006
CompletedFirst Submitted
Initial submission to the registry
January 18, 2006
CompletedFirst Posted
Study publicly available on registry
January 20, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 3, 2012
November 1, 2012
1.6 years
January 18, 2006
November 29, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate all cause mortality at Day 28
Secondary Outcomes (1)
To assess the effect of RAD treatment in measures of patient's safety and clinical outcome
Interventions
Eligibility Criteria
You may qualify if:
- A clinical diagnosis of Acute Tubular Necrosis (ATN)
- At least one non-renal organ failure
You may not qualify if:
- A renal transplant at any time
- Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)
- Chronic
- Chronic immunosuppressive therapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University of Alabama
Birmingham, Alabama, 35233, United States
Denver Nephrologists, PC
Denver, Colorado, 80230, United States
George Washington University Hospital
Washington D.C., District of Columbia, 20037, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02120, United States
WNERTA
Springfield, Massachusetts, 01107, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Southeast Renal Associates
Charlotte, North Carolina, 28208, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Texas
Houston, Texas, 77030, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 18, 2006
First Posted
January 20, 2006
Study Start
January 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
December 3, 2012
Record last verified: 2012-11