Acute Kidney InjuryPhase 2ACT-AKINCT01602328
A Study to Evaluate the Safety and Efficacy of AC607 for the Treatment of Kidney Injury in Cardiac Surgery Subjects
A Phase 2 study testing AC607 in people with Acute Kidney Injury, run by AlloCure Inc. at 31 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- AC607
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 31 sitesin 2 countries
- Study dates
- Jun 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
31 sites in 2 countries.
31 sites in 2 countries
United States21 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Fletcher Allen Health Care - Renal Services
Burlington, Vermont, 05401
CAMC Clinical Trials Center
Charleston, West Virginia, 25304
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Henry Ford Hospital
Detroit, Michigan, 48202
Duke University Medical Center
Durham, North Carolina, 27710
UTHealth, The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Columbia University Medical Center
New York, New York, 10032
Maine Medical Center
Portland, Maine, 04102
Mayo Clinic
Rochester, Minnesota, 55905
University of California, San Diego
San Diego, California, 92103
University of Washington Medical Center
Seattle, Washington, 98195
Stanford Hospital and Clinics
Stanford, California, 94305-2299
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Canada10 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
CDHA Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, B3H 3A7
McMaster - Hamilton General Hospital / TAARI
Hamilton, Ontario, L8L 2X2
London Health Sciences Centre, University Hospital
London, Ontario, N6J 1S1
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Toronto General Hospital
Toronto, Ontario, M5G 2C4
University of Manitoba - St. Boniface Hospital
Winnipeg, Manitoba, R2H 2A6
About this study
Official title: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
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).
Read the 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).
- Conditions
- Acute Kidney Injury
- Being tested
- AC607, Vehicle Only
- Keywords
- Acute Kidney Injury, Acute renal failure, Human mesenchymal stem cells, Allogeneic stem cells
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC607Biological
Also called allogeneic bone marrow-derived human mesenchymal, stem cells
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
Vehicle OnlyBiological
The dose will be calculated and recorded in the same way as for AC607.
| Study group | Role | What they receive |
|---|---|---|
| AC607 | Active comparator | Treatment with AC607 Receives: Biological: AC607 |
| Placebo | Placebo comparator | Treatment with Placebo Receives: Biological: Vehicle Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 30 days of dosing.
Secondary outcomes (1)
All-Cause Mortality or Dialysis (composite endpoint).
Measured: Subjects who died or received dialysis within 30 and 90 days after dosing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlloCure Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Viken Paragamian, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602328
- Sponsor's protocol ID
- AC 6071103
- Acronym
- ACT-AKI
- Status last verified
- Aug 2014
- First submitted
- 17 May 2012
- Last updated
- 6 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30484934
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study of AC607 for the Treatment of Acute Kidney Injury in Cardiac Surgery Subjects
- ClinicalTrials.gov ID
- NCT01602328
- Acronym / sponsor ID
- ACT-AKI / AC 6071103
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Acute renal failure, Human mesenchymal stem cells, Allogeneic stem cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 156 participants (actual)
- Lead sponsor
- AlloCure Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC607 | Active comparator | Biological: AC607Treatment with AC607 |
| Placebo | Placebo comparator | Biological: Vehicle OnlyTreatment with Placebo |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC607Also: allogeneic bone marrow-derived human mesenchymal, stem cellsAC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight | Biological | AC607 |
| Vehicle OnlyThe dose will be calculated and recorded in the same way as for AC607. | Biological | Placebo |
Primary outcome
Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values.
Time frame: Within 30 days of dosing.
The first occurrence of a post-dosing serum creatinine level that is equal to or less than the subject's pre-operative baseline level.
1 secondary outcome
All-Cause Mortality or Dialysis (composite endpoint).
Time frame: Subjects who died or received dialysis within 30 and 90 days after dosing.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
- Derived from this study: PubMed 30484934Zhao 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viken Paragamian study director
31 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC607 in people with Acute Kidney Injury, run by AlloCure Inc. at 31 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Kidney Recovery defined as a post-operative serum creatinine return to pre-operative baseline values. (time frame: Within 30 days of dosing.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01602328, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.