Clinical trial NCT00280072: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Kidney Failure, Acute
Keywords: Renal Failure, Acute
Acute Kidney Failure
Acute Renal Failure
Acute Tubular Necrosis
Anuria
Renal Dialysis
Acute Kidney Injury
Lead sponsor: RenaMed Biologics
Sponsor class: INDUSTRY
First posted: 2006-01-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate all cause mortality at Day 28
Secondary outcomes:
measure: To assess the effect of RAD treatment in measures of patient's safety and clinical outcome
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama
state: Alabama
city: Denver
country: United States
facility: Denver Nephrologists, PC
state: Colorado
city: Washington
country: United States
facility: George Washington University Hospital
state: District of Columbia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Springfield
country: United States
facility: WNERTA
state: Massachusetts
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Charlotte
country: United States
facility: Southeast Renal Associates
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
city: Houston
country: United States
facility: University of Texas
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
References: