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

Inclusion Criteria

• A patient, or legal representative, has signed a written informed consent form.
• Must be receiving medical care in an intensive care unit (e.g., ICU, MICU, SICU, CTICU, Trauma, Mixed, other).
• Age 18 to 80 years.
• Females of child bearing potential who are not pregnant (confirmed by a negative serum pregnancy test) and not lactating if recently post-partum.
• Must be receiving and tolerating CRRT therapy for a minimum of 4 hours, but not longer than 24 hours.
• Expected to remain in the ICU for at least 96 hours after evaluation for enrollment.
• A clinical diagnosis of ATN due to hemodynamic or toxic etiologies. ATN is defined as acute renal failure occurring in a setting of acute ischemic or nephrotoxic injury with oliguria (average 6-12 hours or: an increase in serum creatinine ≥2 mg/dL (≥1.5 mg/dL in females) over a period of ≤4 days. (Note: Prerenal, hepatorenal, vascular, interstitial, glomerular, and obstructive etiologies are excluded on clinical or other diagnostic grounds.)
• At least one non-renal organ failure (modified SOFA organ system score >2), as defined in Appendix A or presence (proven or suspected) of sepsis as defined in Appendix B.
• All patients must be able to tolerate regional citrate anticoagulation.

Exclusion Criteria

• Contraindications to regional citrate anticoagulation.
• Irreversible brain damage based on available historical and clinical information.
• Presence of a renal transplant at any time.
• Non-candidacy for acute renal replacement therapy.
• Non-renal organ transplantation within six months of screening date.
• 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).
• 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.
• Metastatic malignancy which is actively being treated or may be treated by chemotherapy or radiation during the subsequent three month period after study therapy
• 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
• Severe liver failure as documented by a Child-Pugh Liver Failure Score >12.
• Do Not Resuscitate (DNR) status.
• Comfort measures only.
• Patient is moribund or for whom full supportive care is not indicated.
• 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.
• Physician refusal.
• Patient pregnant.
• Patient is a prisoner.
• Pre-morbid weight >128.5 kg.
• More than one hemodialysis treatment or longer than 24 hours since starting CRRT.
• Platelet count <30,000/mm3.
• 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.
• Use of any other Investigational drug or device within the previous 30 days.