Back to resultsOpen-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
Primary Purpose
Acute Renal Failure
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Renal tubule assist device
Sponsored by
About this trial
This is an interventional treatment trial for Acute Renal Failure focused on measuring Acute renal failure, Bioartificial kidney, Cell therapy, Hemofiltration, Septic shock
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.
Sites / Locations
- University of Alabama
- Medical College of Georgia
- University of Chicago
- Indiana University
- University of Maryland
- Massachusetts General Hospital
- Western New England Renal and Transplant Associates
- University of Michigan
- Southeast Renal Associates/Presbyterian Hospital
- Cleveland Clinic Foundation
- Rhode Island Hospital
- University of Texas
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
I
II
Arm Description
RAD Treatment
Conventional CVVHD
Outcomes
Primary Outcome Measures
All-cause mortality
Time to recovery of renal function
Time to ICU and hospital discharge
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00511407
Brief Title
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
RenaMed Biologics
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Renal Failure
Keywords
Acute renal failure, Bioartificial kidney, Cell therapy, Hemofiltration, Septic shock
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
I
Arm Type
Experimental
Arm Description
RAD Treatment
Arm Title
II
Arm Type
No Intervention
Arm Description
Conventional CVVHD
Intervention Type
Device
Intervention Name(s)
Renal tubule assist device
Intervention Description
Standard hemofiltration cartridge containing nonautologous human renal tubule cells, connected to conventional continuous venovenous hemodialysis circuit.
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
28, 90, and 180 d
Title
Time to recovery of renal function
Time Frame
180 d
Title
Time to ICU and hospital discharge
Time Frame
180 d
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35203
Country
United States
Facility Name
Medical College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Western New England Renal and Transplant Associates
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Southeast Renal Associates/Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28208
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Study To Evaluate the Safety and Efficacy of the Renal Assist Device In Patients With Acute Renal Failure
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