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

This study has been terminated.
Sponsor:
Information provided by:
RenaMed Biologics
ClinicalTrials.gov Identifier:
NCT00280072
First received: January 18, 2006
Last updated: November 29, 2012
Last verified: November 2012
  Purpose
  • 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

Condition Intervention Phase
Kidney Failure, Acute
Device: Renal Assist Device
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by RenaMed Biologics:

Primary Outcome Measures:
  • To evaluate all cause mortality at Day 28

Secondary Outcome Measures:
  • To assess the effect of RAD treatment in measures of patient's safety and clinical outcome

Study Start Date: January 2006
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280072

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35233
United States, Colorado
Denver Nephrologists, PC
Denver, Colorado, United States, 80230
United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
University of Maryland
Baltimore, Maryland, United States, 21201
Johns Hopkins University
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02120
WNERTA
Springfield, Massachusetts, United States, 01107
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, North Carolina
Southeast Renal Associates
Charlotte, North Carolina, United States, 28208
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Texas
University of Texas
Houston, Texas, United States, 77030
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
RenaMed Biologics
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00280072     History of Changes
Other Study ID Numbers: RAD-003
Study First Received: January 18, 2006
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by RenaMed Biologics:
Renal Failure, Acute
Acute Kidney Failure
Acute Renal Failure
Acute Tubular Necrosis
Anuria
Renal Dialysis
Acute Kidney Injury

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 19, 2014