A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
ACT-AKI
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
1 other identifier
interventional
156
2 countries
31
Brief Summary
Subjects entering the study will have undergone cardiac surgery. Those who experience kidney injury within 48 hours of their surgery will be enrolled into the study. Once enrolled, subjects will receive a single administration of AC607 or placebo. Kidney recovery will be evaluated over the subsequent 30 days and death or the need for dialysis will be evaluated within 90 days of dosing. After 90 days (evaluation period), subjects will enter a 3-year extension phase of the study to monitor safety and long-term outcomes (follow-up period).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2012
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2012
CompletedFirst Posted
Study publicly available on registry
May 21, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 6, 2014
August 1, 2014
2 years
May 17, 2012
August 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values.
The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.
Within 30 days of dosing.
Secondary Outcomes (1)
All-Cause Mortality or Dialysis (composite endpoint).
Subjects who died or received dialysis within 30 and 90 days after dosing.
Study Arms (2)
AC607
ACTIVE COMPARATORTreatment with AC607
Placebo
PLACEBO COMPARATORTreatment with Placebo
Interventions
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Eligibility Criteria
You may qualify if:
- Age ≥ 21 years
- 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
You may not qualify if:
- Active cancer and/or receiving active treatment for cancer, with the exception of squamous cell or basal cell carcinoma of the skin
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AlloCure Inc.lead
Study Sites (31)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
University of California, San Diego
San Diego, California, 92103, United States
Stanford Hospital and Clinics
Stanford, California, 94305-2299, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Northwestern University
Chicago, Illinois, 60611, United States
Maine Medical Center
Portland, Maine, 04102, United States
Johns Hopkins University
Baltimore, Maryland, 21287, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903, United States
Columbia University Medical Center
New York, New York, 10032, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Ohio State University
Columbus, Ohio, 43210, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
UTHealth, The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Fletcher Allen Health Care - Renal Services
Burlington, Vermont, 05401, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University of Washington Medical Center
Seattle, Washington, 98195, United States
CAMC Clinical Trials Center
Charleston, West Virginia, 25304, United States
Foothills Medical Centre
Calgary, Alberta, T2N 2T9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
University of Manitoba - St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
CDHA Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7, Canada
McMaster - Hamilton General Hospital / TAARI
Hamilton, Ontario, L8L 2X2, Canada
London Health Sciences Centre, University Hospital
London, Ontario, N6J 1S1, Canada
St. Michael's Hospital
Toronto, Ontario, M5B 1W8, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Montreal Heart Institute
Montreal, Quebec, H1T 1C8, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Related Publications (1)
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.
PMID: 30484934DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Viken Paragamian
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2012
First Posted
May 21, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
August 6, 2014
Record last verified: 2014-08