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

This study has been completed.
Sponsor:
Information provided by:
RenaMed Biologics
ClinicalTrials.gov Identifier:
NCT00511407
First received: August 2, 2007
Last updated: November 29, 2012
Last verified: November 2012
  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

Resource links provided by NLM:


Further study details as provided by RenaMed Biologics:

Primary Outcome Measures:
  • 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
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511407

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
Sponsors and Collaborators
RenaMed Biologics
  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 August 18, 2014