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

Primary Purpose

Kidney Failure, Acute

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Renal Assist Device
Sponsored by
RenaMed Biologics
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure, Acute focused on measuring Renal Failure, Acute, Acute Kidney Failure, Acute Renal Failure, Acute Tubular Necrosis, Anuria, Renal Dialysis, Acute Kidney Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Denver Nephrologists, PC
  • George Washington University Hospital
  • University of Chicago
  • Indiana University
  • University of Maryland
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Brigham & Women's Hospital
  • WNERTA
  • Mayo Clinic
  • Washington University
  • Southeast Renal Associates
  • Ohio State University Medical Center
  • University of Texas
  • Virginia Commonwealth University

Outcomes

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

Full Information

First Posted
January 18, 2006
Last Updated
November 29, 2012
Sponsor
RenaMed Biologics
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1. Study Identification

Unique Protocol Identification Number
NCT00280072
Brief Title
Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Terminated
Study Start Date
January 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
RenaMed Biologics

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Acute
Keywords
Renal Failure, Acute, Acute Kidney Failure, Acute Renal Failure, Acute Tubular Necrosis, Anuria, Renal Dialysis, Acute Kidney Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Renal Assist Device
Primary Outcome Measure Information:
Title
To evaluate all cause mortality at Day 28
Secondary Outcome Measure Information:
Title
To assess the effect of RAD treatment in measures of patient's safety and clinical outcome

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Denver Nephrologists, PC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
WNERTA
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Southeast Renal Associates
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

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

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