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

  Show 31 Study Locations
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
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014