Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
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Purpose
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 |
|---|---|---|
|
Acute Renal Failure |
Device: Renal tubule assist device |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- All-cause mortality [ Time Frame: 28, 90, and 180 d ]
- Time to recovery of renal function [ Time Frame: 180 d ]
- Time to ICU and hospital discharge [ Time Frame: 180 d ]
| Enrollment: | 58 |
| Study Start Date: | March 2004 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: I
RAD Treatment
|
Device: Renal tubule assist device
Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
|
|
No Intervention: II
Conventional CVVHD
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations| 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 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00511407 History of Changes |
| Other Study ID Numbers: | RAD-002 |
| Study First Received: | August 2, 2007 |
| Last Updated: | November 29, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by RenaMed Biologics:
|
Acute renal failure Bioartificial kidney Cell therapy Hemofiltration Septic shock |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013