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Sponsored by: |
RenaMed Biologics |
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Information provided by: | RenaMed Biologics |
ClinicalTrials.gov Identifier: | NCT00511407 |
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.
Condition | Intervention | Phase |
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Acute Renal Failure |
Device: Renal tubule assist device |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Phase II Study To Assess Safety and Efficacy With the Renal Assist Device (RAD) In Patients With Acute Renal Failure |
Enrollment: | 58 |
Study Start Date: | March 2004 |
Arms | Assigned Interventions |
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I: Experimental
RAD Treatment
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Device: Renal tubule assist device
Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
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II: No Intervention
Conventional CVVHD
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Acute Renal Failure (ARF) is a severe inflammatory disease state often accompanied by Multi-Organ Failure (MOF) and Systemic Inflammatory Response Syndrome (SIRS). ARF is precipitated by many factors and is most often linked to the loss of kidney tubule cell function. Patients with ARF are treated in the intensive care units of hospitals, and recovery of renal function is vitally important to their survival. Current therapy for ARF involves conventional kidney support with continuous renal replacement therapies (CRRT). Despite advances in treating patients with CRRT, ARF has an extremely high mortality rate (55-70%) and requires extensive hospital stays, predominantly in the ICU. The RAD is designed to both treat ARF with MOF and/or SIRs and facilitate the natural recovery of a patient's own kidney function. The RAD is intended for use for short periods of time in conventional extracorporeal therapeutic systems that are already available in the hospital. The RAD therapy operates outside the body and is designed to mimic the structure and function of the natural kidney. In this manner it is intended to replace the missing metabolic, endocrine, and immunologic functions of the kidney and allow time for the patient's own kidneys to resume normal functions.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
University of Alabama | |
Birmingham, Alabama, United States, 35203 | |
United States, Georgia | |
Medical College of Georgia | |
Augusta, Georgia, United States, 30912 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Western New England Renal and Transplant Associates | |
Springfield, Massachusetts, United States, 01107 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, North Carolina | |
Southeast Renal Associates/Presbyterian Hospital | |
Charlotte, North Carolina, United States, 28208 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Rhode Island | |
Rhode Island Hospital | |
Providence, Rhode Island, United States, 02903 | |
United States, Texas | |
University of Texas | |
Houston, Texas, United States, 77004 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23219 |
Study ID Numbers: | RAD-002 |
Study First Received: | August 2, 2007 |
Last Updated: | August 2, 2007 |
ClinicalTrials.gov Identifier: | NCT00511407 |
Health Authority: | United States: Food and Drug Administration |
Acute renal failure Bioartificial kidney Cell therapy Hemofiltration Septic shock |
Renal Insufficiency Urologic Diseases Shock Shock, Septic |
Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Kidney Failure |