Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure

NCT ID: NCT00511407

Last Updated: 2012-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-03-31
• Study Completion Date: 2007-08-31

Brief Summary

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.

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.

Conditions

Acute Renal Failure

Keywords

Acute renal failure; Bioartificial kidney; Cell therapy; Hemofiltration; Septic shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

I

RAD Treatment

Group Type: EXPERIMENTAL

Renal tubule assist device

Intervention Type: DEVICE

Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.

II

Conventional CVVHD

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Renal tubule assist device

Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenaMed Biologics

INDUSTRY

Sponsor Role: lead

Locations

University of Alabama

Birmingham, Alabama, United States

Medical College of Georgia

Augusta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

University of Maryland

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Western New England Renal and Transplant Associates

Springfield, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Southeast Renal Associates/Presbyterian Hospital

Charlotte, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Rhode Island Hospital

Providence, Rhode Island, United States

University of Texas

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

RAD-002

Identifier Type: -

Identifier Source: org_study_id