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

NCT00511407 | Completed Phase 2 DMC

• 1 other identifier: RAD-002
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Renal Failure

Keywords

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

Outcome Measures

Primary Outcomes (3)

• All-cause mortality

  28, 90, and 180 d

• Time to recovery of renal function

  180 d

• Time to ICU and hospital discharge

  180 d

Study Arms (2)

I

EXPERIMENTAL

RAD Treatment

Device: Renal tubule assist device

II

NO INTERVENTION

Conventional CVVHD

Interventions

Renal tubule assist device DEVICE

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

I

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RenaMed Biologics: lead

Study Sites (13)

University of Alabama

Birmingham, Alabama, 35203, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Western New England Renal and Transplant Associates

Springfield, Massachusetts, 01107, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Southeast Renal Associates/Presbyterian Hospital

Charlotte, North Carolina, 28208, United States

Location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

University of Texas

Houston, Texas, 77004, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

MeSH Terms

Conditions

Acute Kidney Injury; Shock, Septic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 3, 2007
• Study Start: March 1, 2004
• Primary Completion: August 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 3, 2012

Record last verified: 2012-11

Locations

US (13)