Study to Evaluate the Safety and Efficacy of the Renal Assist Device in Patients With Acute Renal Failure
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00280072 |
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Recruitment Status :
Terminated
First Posted : January 20, 2006
Last Update Posted : December 3, 2012
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Sponsor:
RenaMed Biologics
Information provided by:
RenaMed Biologics
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Brief Summary:
- The purpose of this study is to evaluate the safety and efficacy of the RAD to determine whether the RAD is effective in reducing mortality in patients with Acute Renal Failure due to Acute Tubule Necrosis and to evaluate the safety of the RAD
- If the RAD works normally when used for as long as 72 hours
- If the RAD will provide added benefits to normal CVVH therapy for patients with Acute Renal Failure
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Kidney Failure, Acute | Device: Renal Assist Device | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double |
| Primary Purpose: | Treatment |
| 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 |
| Actual Primary Completion Date : | August 2007 |
| Actual Study Completion Date : | August 2007 |
Primary Outcome Measures :
- To evaluate all cause mortality at Day 28
Secondary Outcome Measures :
- To assess the effect of RAD treatment in measures of patient's safety and clinical outcome
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- A clinical diagnosis of Acute Tubular Necrosis (ATN)
- At least one non-renal organ failure
Exclusion Criteria:
- A renal transplant at any time
- Chronic renal failure occurring due to reasons other than Acute Tubular Necrosis (ATN)
- Chronic
- Chronic immunosuppressive therapy
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00280072
Locations
| 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 | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Brigham & Women's Hospital | |
| Boston, Massachusetts, United States, 02120 | |
| WNERTA | |
| Springfield, Massachusetts, United States, 01107 | |
| 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 | |
Sponsors and Collaborators
RenaMed Biologics
| ClinicalTrials.gov Identifier: | NCT00280072 History of Changes |
| Other Study ID Numbers: |
RAD-003 |
| First Posted: | January 20, 2006 Key Record Dates |
| Last Update Posted: | December 3, 2012 |
| Last Verified: | November 2012 |
Keywords provided by RenaMed Biologics:
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Renal Failure, Acute Acute Kidney Failure Acute Renal Failure Acute Tubular Necrosis |
Anuria Renal Dialysis Acute Kidney Injury |
Additional relevant MeSH terms:
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Renal Insufficiency Acute Kidney Injury Kidney Diseases Urologic Diseases |