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

Acute Kidney Injury Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01602328
• Other study ID #: AC 6071103
• Status: Terminated
• Phase: Phase 2
• First received: May 17, 2012
• Last updated: August 5, 2014
• Start date: June 2012
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: AlloCure Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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. 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).

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 156
• Est. completion date: August 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

Biological:
• AC607
AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
• Vehicle Only
The dose will be calculated and recorded in the same way as for AC607.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	CDHA Queen Elizabeth II Health Sciences Centre	Halifax	Nova Scotia
Canada	McMaster - Hamilton General Hospital / TAARI	Hamilton	Ontario
Canada	London Health Sciences Centre, University Hospital	London	Ontario
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Quebec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	University of Manitoba - St. Boniface Hospital	Winnipeg	Manitoba
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Fletcher Allen Health Care - Renal Services	Burlington	Vermont
United States	CAMC Clinical Trials Center	Charleston	West Virginia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	UTHealth, The University of Texas Health Science Center at Houston	Houston	Texas
United States	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Columbia University Medical Center	New York	New York
United States	Maine Medical Center	Portland	Maine
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, San Diego	San Diego	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford Hospital and Clinics	Stanford	California
United States	MedStar Washington Hospital Center	Washington	District of Columbia
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
AlloCure Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 30 days of dosing.	No
Secondary	All-Cause Mortality or Dialysis (composite endpoint).		Subjects who died or received dialysis within 30 and 90 days after dosing.	No