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Efficacy and Safety of Renal Tubule Cell Therapy for Acute Renal Failure

James Tumlin^*, Ravinder Wali, Winfred Williams, Patrick Murray, Ashita J. Tolwani^||, Anna K. Vinnikova^¶, Harold M. Szerlip^**, Jiuming Ye, Emil P. Paganini, Lance Dworkin, Kevin W. Finkel^||||, Michael A. Kraus^¶¶ and H. David Humes^***

^* Southeast Renal Associates/Presbyterian Hospital, Charlotte, North Carolina; Department of Medicine, University of Maryland, Baltimore, Maryland; Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts; Department of Medicine, University of Chicago, Chicago, Illinois; ^|| Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama; ^¶ Department of Internal Medicine, Virginia Commonwealth University, Richmond, Virginia; ^** Department of Medicine, Medical College of Georgia, Augusta, Georgia; Western New England Renal and Transplant Associates, Springfield, Massachusetts; Department of Nephrology and Hypertension, Cleveland Clinic Foundation, Cleveland, Ohio; Rhode Island Hospital, Providence, Rhode Island; ^|||| Department of Internal Medicine, University of Texas, Houston, Texas; ^¶¶ Department of Medicine, Indiana University, Indianapolis, Indiana; and ^*** Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan

Correspondence: Dr. H. David Humes, Division of Nephrology, Department of Internal Medicine, 4520 MSRB I, SPC 5651, 1150 W. Medical Center Drive, Ann Arbor, MI 48109. Phone: 734-647-8018; Fax: 734-763-4851; E-mail: dhumes{at}med.umich.edu

Received for publication August 14, 2007. Accepted for publication December 12, 2007.

The mortality rate for patients with acute renal failure (ARF) remains unacceptably high. Although dialysis removes waste products and corrects fluid imbalance, it does not perform the absorptive, metabolic, endocrine, and immunologic functions of normal renal tubule cells. The renal tubule assist device (RAD) is composed of a conventional hemofilter lined by monolayers of renal cells. For testing whether short-term (up to 72 h) treatment with the RAD would improve survival in patients with ARF compared with conventional continuous renal replacement therapy (CRRT), a Phase II, multicenter, randomized, controlled, open-label trial involving 58 patients who had ARF and required CRRT was performed. Forty patients received continuous venovenous hemofiltration + RAD, and 18 received CRRT alone. The primary efficacy end point was all-cause mortality at 28 d; additional end points included all-cause mortality at 90 and 180 d, time to recovery of renal function, time to intensive care unit and hospital discharge, and safety. At day 28, the mortality rate was 33% in the RAD group and 61% in the CRRT group. Kaplan-Meier analysis revealed that survival through day 180 was significantly improved in the RAD group, and Cox proportional hazards models suggested that the risk for death was approximately 50% of that observed in the CRRT-alone group. RAD therapy was also associated with more rapid recovery of kidney function, was well tolerated, and had the expected adverse event profile for critically ill patients with ARF.

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Copyright © 2008 by the American Society of Nephrology. Online ISSN: 1533-3450 Print ISSN: 1046-6673