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

Sponsor

RenaMed Biologics (Industry)

Overall Status

Terminated

CT.gov ID

NCT00280072

Collaborator

(none)

Locations

Duration (Months)

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Kidney Failure, Acute	Device: Renal Assist Device	Phase 2

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

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

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Aug 1, 2007

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35233
2	Denver Nephrologists, PC	Denver	Colorado	United States	80230
3	George Washington University Hospital	Washington	District of Columbia	United States	20037
4	University of Chicago	Chicago	Illinois	United States	60637
5	Indiana University	Indianapolis	Indiana	United States	46202
6	University of Maryland	Baltimore	Maryland	United States	21201
7	Johns Hopkins University	Baltimore	Maryland	United States	21205
8	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
9	Brigham & Women's Hospital	Boston	Massachusetts	United States	02120
10	WNERTA	Springfield	Massachusetts	United States	01107
11	Mayo Clinic	Rochester	Minnesota	United States	55905
12	Washington University	St. Louis	Missouri	United States	63110
13	Southeast Renal Associates	Charlotte	North Carolina	United States	28208
14	Ohio State University Medical Center	Columbus	Ohio	United States	43210
15	University of Texas	Houston	Texas	United States	77030
16	Virginia Commonwealth University	Richmond	Virginia	United States	23298