A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
NCT ID: NCT01602328
Last Updated: 2014-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
156 participants
INTERVENTIONAL
2012-06-30
2014-08-31
Brief Summary
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Detailed Description
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Safety and efficacy assessments will be performed daily during the post-operative hospital stay from the day randomized into the study until discharge, at 30 days, and at 90 days after study drug administration (evaluation phase). Safety and long-term clinical outcomes will be assessed at 6, 12, 24 and 36 months (long-term follow-up phase).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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AC607
Treatment with AC607
AC607
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Placebo
Treatment with Placebo
Vehicle Only
The dose will be calculated and recorded in the same way as for AC607.
Interventions
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AC607
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Vehicle Only
The dose will be calculated and recorded in the same way as for AC607.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Had cardiovascular surgery utilizing cardiopulmonary bypass
* Have a pre-operative (baseline) serum creatinine value collected within 30 days of surgery (if multiple laboratory results are available within this time window, the most recent serum creatinine value prior to surgery will be used to establish the baseline)
* Willing and able to comply with visit schedule and study procedures including post-hospitalization discharge follow-up
* Ability to give informed consent or have a legally acceptable representative do so for them
* Have AKI defined as ≥ 0.5 mg/dL rise in serum creatinine from baseline within 48 hours of removal from cardiopulmonary bypass
Exclusion Criteria
* Had surgery for thoraco-abdominal aortic aneurysm (TAAA)
* Currently participating in another interventional drug or device clinical study
* Prisoner or other detainee
* Has a current medical condition that would preclude or compromise femoral artery catheter placement
* Has an intra-aortic balloon pump (IABP) in place within 2 hours of catheter placement
* Has a ventricular assist device (VAD) or extracorporeal membrane oxygenation (ECMO) in place at the time of the study catheter placement
* Prior history of solid organ or bone marrow transplant
* Stage 5 CKD or currently on dialysis
* Are expected to receive dialysis within 24 hours of enrollment or dosing
* Had a complication during surgery or post-operatively that, in the opinion of the principal investigator (PI), significantly increases the risk of complications to the subject and therefore precludes dosing the subject
* Are pregnant or lactating. A woman with child-bearing potential may be tested for pregnancy at the discretion of the PI.
21 Years
ALL
No
Sponsors
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AlloCure Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Viken Paragamian
Role: STUDY_DIRECTOR
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of California, San Diego
San Diego, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Northwestern University
Chicago, Illinois, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, United States
UTHealth, The University of Texas Health Science Center at Houston
Houston, Texas, United States
Fletcher Allen Health Care - Renal Services
Burlington, Vermont, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Washington Medical Center
Seattle, Washington, United States
CAMC Clinical Trials Center
Charleston, West Virginia, United States
Foothills Medical Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
University of Manitoba - St. Boniface Hospital
Winnipeg, Manitoba, Canada
CDHA Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
McMaster - Hamilton General Hospital / TAARI
Hamilton, Ontario, Canada
London Health Sciences Centre, University Hospital
London, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Countries
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References
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Zhao L, Hu C, Zhang P, Jiang H, Chen J. Preconditioning strategies for improving the survival rate and paracrine ability of mesenchymal stem cells in acute kidney injury. J Cell Mol Med. 2019 Feb;23(2):720-730. doi: 10.1111/jcmm.14035. Epub 2018 Nov 28.
Other Identifiers
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AC 6071103
Identifier Type: -
Identifier Source: org_study_id
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