Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure

NCT ID: NCT00280072

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2007-08-31

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.

Conditions

Kidney Failure, Acute

Keywords

Renal Failure, Acute; Acute Kidney Failure; Acute Renal Failure; Acute Tubular Necrosis; Anuria; Renal Dialysis; Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Renal Assist Device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A clinical diagnosis of Acute Tubular Necrosis (ATN)
• At least one non-renal organ failure

Exclusion Criteria

• A renal transplant at any time
• Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)
• Chronic
• Chronic immunosuppressive therapy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenaMed Biologics

INDUSTRY

Sponsor Role: lead

Locations

University of Alabama

Birmingham, Alabama, United States

Denver Nephrologists, PC

Denver, Colorado, United States

George Washington University Hospital

Washington D.C., District of Columbia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

WNERTA

Springfield, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University

St Louis, Missouri, United States

Southeast Renal Associates

Charlotte, North Carolina, United States

Ohio State University Medical Center

Columbus, Ohio, United States

University of Texas

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

RAD-003

Identifier Type: -

Identifier Source: org_study_id