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Sponsored by: |
RenaMed Biologics |
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Information provided by: | RenaMed Biologics |
ClinicalTrials.gov Identifier: | NCT00280072 |
Condition | Intervention | Phase |
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Kidney Failure, Acute |
Device: Renal Assist Device |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Controlled, Double-Blind, Phase II Study To Assess Safety and Efficacy With the Renal Assist Device (RAD) in Patients With Acute Renal Failure |
Study Start Date: | January 2006 |
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, 35233 | |
United States, Colorado | |
Denver Nephrologists, PC | |
Denver, Colorado, United States, 80230 | |
United States, District of Columbia | |
George Washington University Hospital | |
Washington, District of Columbia, United States, 20037 | |
United States, Illinois | |
University of Chicago | |
Chicago, Illinois, United States, 60637 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
University of Maryland | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
WNERTA | |
Springfield, Massachusetts, United States, 01107 | |
Brigham & Women's Hospital | |
Boston, Massachusetts, United States, 02120 | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Washington University | |
St. Louis, Missouri, United States, 63110 | |
United States, North Carolina | |
Southeast Renal Associates | |
Charlotte, North Carolina, United States, 28208 | |
United States, Ohio | |
Ohio State University Medical Center | |
Columbus, Ohio, United States, 43210 | |
United States, Texas | |
University of Texas | |
Houston, Texas, United States, 77030 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Study ID Numbers: | RAD-003 |
Study First Received: | January 18, 2006 |
Last Updated: | November 10, 2006 |
ClinicalTrials.gov Identifier: | NCT00280072 |
Health Authority: | United States: Food and Drug Administration |
Renal Failure, Acute Acute Kidney Failure Acute Renal Failure Acute Tubular Necrosis |
Anuria Renal Dialysis Acute Kidney Injury |
Renal Insufficiency Necrosis Urologic Diseases Kidney Tubular Necrosis, Acute |
Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Kidney Failure |