Safety Study of a Selective Cytopheretic Device (SCD) in Patients With Acute Renal Failure

Exclusion Criteria

• •1. Contraindications to regional citrate anticoagulation.
• •2. Irreversible brain damage based on available historical and clinical information.
• •3. Presence of a renal transplant at any time.
• •4. Non-candidacy for acute renal replacement therapy.
• •5. Non-renal organ transplantation within six months of screening date.
• •6. Presence of preexisting chronic renal failure prior to this episode of ARF. Preexisting chronic renal failure is defined as baseline serum creatinine \>2.5 mg/dL (men), or \>2.0 mg/dL (women).
• •7. ARF 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.
• •8. Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
• •9. Chronic immunosuppression (e.g., AIDS, chronic glucocorticoid therapy \>20 mg/day prednisone equivalent on a chronic basis, or chemotherapy). The acute use of glucocorticoids is permissible
• •10. Severe liver failure as documented by a Child-Pugh Liver Failure Score \>12.
• •11. Do Not Resuscitate (DNR) status.
• •12. Comfort measures only.
• •13. Patient is moribund or for whom full supportive care is not indicated.
• •14. Patient not expected to survive 28 days because of an irreversible medical condition.
• •15. Any medical condition that the Investigator thinks may interfere with the study objectives.
• •16. Physician refusal.
• •17. Patient pregnant.
• •18. Patient is a prisoner.
• •19. Pre-morbid weight \>128.5 kg.
• •20. More than one hemodialysis treatment or longer than 24 hours since starting CRRT.
• •21. Platelet count \<30,000/mm3.
• •22. Concurrent enrollment in another interventional clinical trial. Patients enrolled in clinical trials where only measurements and or samples are taken (NO TEST DEVICE OR DRUG USED) are allowed to participate.
• •23. Use of any other Investigational drug or device within the previous 30 days.