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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Acute Kidney Injury

In brief

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).

Key facts

Study ID

NCT01602328

Run by

AlloCure Inc.

People needed

156

Starts

2012-06-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-06

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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