A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects (ACT-AKI)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
AlloCure Inc.
ClinicalTrials.gov Identifier:
NCT01602328
First received: May 17, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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).


Condition Intervention Phase
Acute Kidney Injury
Biological: AC607
Biological: Vehicle Only
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects

Resource links provided by NLM:


Further study details as provided by AlloCure Inc.:

Primary Outcome Measures:
  • Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values. [ Time Frame: Within 30 days of dosing. ] [ Designated as safety issue: No ]
    The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.


Secondary Outcome Measures:
  • All-Cause Mortality or Dialysis (composite endpoint). [ Time Frame: Subjects who died or received dialysis within 30 and 90 days after dosing. ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: June 2012
Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AC607
Treatment with AC607
Biological: AC607
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Other Names:
  • allogeneic bone marrow-derived human mesenchymal
  • stem cells
Placebo Comparator: Placebo
Treatment with Placebo
Biological: Vehicle Only
The dose will be calculated and recorded in the same way as for AC607.

Detailed Description:

The study will enroll post-cardiac surgery subjects (CABG and/or valve) with laboratory evidence of AKI within 48 hrs of removal from cardiopulmonary bypass. Subjects will be randomly assigned (1:1 ratio) to treatment with a single administration of AC607 or placebo (approximately 100 subjects per group).

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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  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: NCT01602328

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, California
University of California, San Diego
San Diego, California, United States, 92103
Stanford Hospital and Clinics
Stanford, California, United States, 94305-2299
United States, District of Columbia
MedStar Washington Hospital Center
Washington, District of Columbia, United States, 20010
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Maine
Maine Medical Center
Portland, Maine, United States, 04102
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New Jersey
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
UTHealth, The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
United States, Vermont
Fletcher Allen Health Care - Renal Services
Burlington, Vermont, United States, 05401
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, West Virginia
CAMC Clinical Trials Center
Charleston, West Virginia, United States, 25304
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Manitoba
University of Manitoba - St. Boniface Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Nova Scotia
CDHA Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Canada, Ontario
McMaster - Hamilton General Hospital / TAARI
Hamilton, Ontario, Canada, L8L 2X2
London Health Sciences Centre, University Hospital
London, Ontario, Canada, N6J 1S1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Canada, Quebec
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
AlloCure Inc.
Investigators
Study Director: Viken Paragamian
  More Information

No publications provided

Responsible Party: AlloCure Inc.
ClinicalTrials.gov Identifier: NCT01602328     History of Changes
Other Study ID Numbers: AC 6071103
Study First Received: May 17, 2012
Last Updated: August 5, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by AlloCure Inc.:
Acute Kidney Injury
Acute renal failure
Human mesenchymal stem cells
Allogeneic stem cells

Additional relevant MeSH terms:
Acute Kidney Injury
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014