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

Completed · Phase 2

Conditions studied: Acute Renal Failure

In brief

Although conventional hemodialysis removes waste products and corrects fluid imbalance, it does not replace critical absorptive, metabolic, endocrine, and immunologic functions performed by healthy renal tubule cells. This trial involving patients with acute renal failure evaluates the efficacy and safety of an extracorporeal renal assist device (RAD) containing human renal tubule cells connected to a conventional hemodialysis circuit. It is hypothesized that short-term (72-h) use of this cell therapeutic device will improve survival of ARF patients compared to patients receiving only conventional continuous renal replacement therapy.

Key facts

Study ID

NCT00511407

Run by

RenaMed Biologics

People needed

58

Starts

2004-03-01

Expected to finish

2007-08-01

Last updated by the study team

2012-12-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-pregnant.
• Requiring continuous renal replacement therapy for treatment of acute renal failure secondary to acute tubular necrosis in ICU setting.
• At least one non-renal organ failure or presence of sepsis.

You may not qualify if…

• 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.

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Western New England Renal and Transplant Associates — Springfield, Massachusetts, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Southeast Renal Associates/Presbyterian Hospital — Charlotte, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• University of Texas — Houston, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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