Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure

Exclusion Criteria

• •Contraindications to systemic anticoagulation with heparin.
• •Irreversible brain damage.
• •Presence of any organ transplant.
• •Presence of preexisting chronic renal failure prior to this episode of acute renal failure.
• •Acute renal failure occurring in the setting of burns, obstructive uropathy, allergic interstitial nephritis, acute or rapidly progressive glomerulonephritis, vasculitis, hemolytic-uremic syndrome, thrombotic thrombocytopenic purpura (TTP), malignant hypertension, scleroderma renal crisis, atheroembolism, functional or surgical nephrectomy, hepatorenal syndrome, cyclosporine or tacrolimus nephrotoxicity.
• •Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after RAD therapy.
• •Chronic immunosuppression.
• •Receiving Xigris therapy at time of randomization.
• •Severe liver failure as documented by a Pugh Liver Failure Score.
• •Do Not Resuscitate (DNR) status.
• •Platelet count 35,000/mm3 within 4 hours of platelet transfusion.
• •Patient not expected to survive 28-days because of an irreversible medical condition.
• •Any medical condition that the investigator thinks may interfere with the study objectives.
• •Concurrent enrollment in another clinical trial that could affect the outcome of this study protocol.
• •Use of any other Investigational drug or device within the previous 30 days.