Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
- Conditions
- Kidney Failure, Acute
- Registration Number
- NCT00280072
- Lead Sponsor
- RenaMed Biologics
- 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
- Detailed Description
Acute Renal Failure (ARF)is a severe inflammatory disease state often accompanied by Multi-Organ Failure (MOF) and Systemic Inflammatory Response Syndrome (SIRS). ARF is precipitated by many factors and is most often linked to the loss of kidney tubule cell function. Patients with ARF are treated in the intensive care units of hospitals and recovery of renal function is vitally important to their survival. Current therapy for ARF involves conventional kidney support with continuous renal replacement therapies (CRRT). Despite advances in treating patients with CRRT, ARF has an extremely high mortality rate (55-70%) and requires extensive hospital stays, predominantly in the ICU. The RAD is designed to both treat ARF with MOF and/or SIRs and facilitate the natural recovery of a patient's own kidney function. The RAD is intended for use for short periods of time in conventional extracorporeal therapeutic systems that are already available in the hospital. The RAD therapy operates outside the body, and is designed to mimic the structure and function of the natural kidney. In this manner it is intended to replace the missing metabolic, endocrine, and immunologic functions of the kidney and allow time for the patient's own kidneys to resume normal functions.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- Not specified
- A clinical diagnosis of Acute Tubular Necrosis (ATN)
- At least one non-renal organ failure
- A renal transplant at any time
- Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)
- Chronic
- Chronic immunosuppressive therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate all cause mortality at Day 28
- Secondary Outcome Measures
Name Time Method To assess the effect of RAD treatment in measures of patient's safety and clinical outcome
Trial Locations
- Locations (16)
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Denver Nephrologists, PC
🇺🇸Denver, Colorado, United States
WNERTA
🇺🇸Springfield, Massachusetts, United States
University of Texas
🇺🇸Houston, Texas, United States
Washington University
🇺🇸St. Louis, Missouri, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Ohio State University Medical Center
🇺🇸Columbus, Ohio, United States
University of Alabama
🇺🇸Birmingham, Alabama, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Southeast Renal Associates
🇺🇸Charlotte, North Carolina, United States
George Washington University Hospital
🇺🇸Washington, District of Columbia, United States
Indiana University
🇺🇸Indianapolis, Indiana, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States