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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Kidney Failure, Acute

Intervention / Treatment
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* Device: Renal Assist Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Renal Assist Device|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate all cause mortality at Day 28 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of RAD treatment in measures of patient's safety and clinical outcome |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal Failure, Acute, Acute Kidney Failure, Acute Renal Failure, Acute Tubular Necrosis, Anuria, Renal Dialysis, Acute Kidney Injury