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

Primary Purpose

Acute Kidney Injury

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AC607
Vehicle Only
Sponsored by
AlloCure Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute Kidney Injury, Acute renal failure, Human mesenchymal stem cells, Allogeneic stem cells

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • University of California, San Diego
  • Stanford Hospital and Clinics
  • MedStar Washington Hospital Center
  • Northwestern University
  • Maine Medical Center
  • Johns Hopkins University
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Henry Ford Hospital
  • Mayo Clinic
  • Rutgers Robert Wood Johnson Medical School
  • Columbia University Medical Center
  • Duke University Medical Center
  • Ohio State University
  • Lankenau Medical Center
  • UTHealth, The University of Texas Health Science Center at Houston
  • Fletcher Allen Health Care - Renal Services
  • University of Virginia Health System
  • University of Washington Medical Center
  • CAMC Clinical Trials Center
  • Foothills Medical Centre
  • University of Alberta Hospital
  • University of Manitoba - St. Boniface Hospital
  • CDHA Queen Elizabeth II Health Sciences Centre
  • McMaster - Hamilton General Hospital / TAARI
  • London Health Sciences Centre, University Hospital
  • St. Michael's Hospital
  • Toronto General Hospital
  • Montreal Heart Institute
  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AC607

Placebo

Arm Description

Treatment with AC607

Treatment with Placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

All-Cause Mortality or Dialysis (composite endpoint).

Full Information

First Posted
May 17, 2012
Last Updated
August 5, 2014
Sponsor
AlloCure Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01602328
Brief Title
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
Acronym
ACT-AKI
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlloCure Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury
Keywords
Acute Kidney Injury, Acute renal failure, Human mesenchymal stem cells, Allogeneic stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
156 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AC607
Arm Type
Active Comparator
Arm Description
Treatment with AC607
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with Placebo
Intervention Type
Biological
Intervention Name(s)
AC607
Other Intervention Name(s)
allogeneic bone marrow-derived human mesenchymal, stem cells
Intervention Description
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Intervention Type
Biological
Intervention Name(s)
Vehicle Only
Intervention Description
The dose will be calculated and recorded in the same way as for AC607.
Primary Outcome Measure Information:
Title
Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values.
Description
The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.
Time Frame
Within 30 days of dosing.
Secondary Outcome Measure Information:
Title
All-Cause Mortality or Dialysis (composite endpoint).
Time Frame
Subjects who died or received dialysis within 30 and 90 days after dosing.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viken Paragamian
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Stanford Hospital and Clinics
City
Stanford
State/Province
California
ZIP/Postal Code
94305-2299
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Rutgers Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
UTHealth, The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Fletcher Allen Health Care - Renal Services
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
CAMC Clinical Trials Center
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
Foothills Medical Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Manitoba - St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Facility Name
CDHA Queen Elizabeth II Health Sciences Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 3A7
Country
Canada
Facility Name
McMaster - Hamilton General Hospital / TAARI
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
London Health Sciences Centre, University Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6J 1S1
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
30484934
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.
Results Reference
derived

Learn more about this trial

A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects

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