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

• 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

Study Overview

• Status: Terminated
• Conditions: Kidney Failure, Acute
• Intervention / Treatment: Device: Renal Assist Device

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To evaluate all cause mortality at Day 28

Secondary Outcome Measures

Outcome Measure
To assess the effect of RAD treatment in measures of patient's safety and clinical outcome

Collaborators and Investigators

• Sponsor: RenaMed Biologics

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): August 1, 2007
• Study Completion (Actual): August 1, 2007

Study Registration Dates

• First Submitted: January 18, 2006
• First Submitted That Met QC Criteria: January 18, 2006
• First Posted (Estimate): January 20, 2006

Study Record Updates

• Last Update Posted (Estimate): December 3, 2012
• Last Update Submitted That Met QC Criteria: November 29, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: Acute Kidney Injury; Renal Dialysis; Acute Kidney Failure; Acute Renal Failure; Acute Tubular Necrosis; Renal Failure, Acute; Anuria
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: RAD-003