Clinical trial NCT01602328: A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Kidney Injury
Keywords: Acute Kidney Injury
Acute renal failure
Human mesenchymal stem cells
Allogeneic stem cells
Lead sponsor: AlloCure Inc.
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 156
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values.
timeFrame: Within 30 days of dosing.
Secondary outcomes:
measure: All-Cause Mortality or Dialysis (composite endpoint).
timeFrame: Subjects who died or received dialysis within 30 and 90 days after dosing.
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Stanford
country: United States
facility: Stanford Hospital and Clinics
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New Brunswick
country: United States
facility: Rutgers Robert Wood Johnson Medical School
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: UTHealth, The University of Texas Health Science Center at Houston
state: Texas
city: Burlington
country: United States
facility: Fletcher Allen Health Care - Renal Services
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Charleston
country: United States
facility: CAMC Clinical Trials Center
state: West Virginia
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: University of Manitoba - St. Boniface Hospital
state: Manitoba
city: Halifax
country: Canada
facility: CDHA Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster - Hamilton General Hospital / TAARI
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre, University Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Quebec
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Study officials:
name: Viken Paragamian
role: STUDY_DIRECTOR
References:
citation: 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.