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

Kidney Failure, Acute Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00280072
• Other study ID #: RAD-003
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2006
• Last updated: November 29, 2012
• Start date: January 2006
• Est. completion date: August 2007

Study information

• Verified date: November 2012
• Source: RenaMed Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Intervention

Device:
• Renal Assist Device

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama	Birmingham	Alabama
United States	Brigham & Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Southeast Renal Associates	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Denver Nephrologists, PC	Denver	Colorado
United States	University of Texas	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	WNERTA	Springfield	Massachusetts
United States	Washington University	St. Louis	Missouri
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
RenaMed Biologics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate all cause mortality at Day 28
Secondary	To assess the effect of RAD treatment in measures of patient's safety and clinical outcome