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



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital
Therapuetic Areas:Nephrology / Urology, Other
Healthy:No
Age Range:21 - Any
Updated:5/5/2014
Start Date:June 2012
End Date:May 2017
Contact:Elizabeth A LaPointe, MA
Email:elapointe@allocure.com
Phone:978-400-8126

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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).

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).

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.
We found this trial at
24
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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201 East Huron Street
Chicago, Illinois 60611
(847) 491-3741
Northwestern University Northwestern is recognized both nationally and internationally for the quality of its educational...
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Chicago, IL
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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9500 Gilman Dr
San Diego, California 92093
(858) 534-2230
University of California at San Diego UC San Diego is dedicated to the advancement of...
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Baltimore, Maryland 20742
(301) 405-1000
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Burlington, VT
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Charleston, West Virginia 25304
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1215 Lee St
Charlottesville, Virginia 22903
(434) 924-0211
University of Virginia Health System UVA Health System includes a 604-bed hospital, level I trauma...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Detroit, MI
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, TX
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New Brunswick, New Jersey 08903
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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3400 Spruce Street
Philadelphia, Pennsylvania 19104
215-662-4000
University of Pennsylvania Health System Today at Penn Medicine, someone will make a breakthrough. Someone...
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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1959 NE Pacific St
Seattle, Washington 98195
(206) 598-3300
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Stanford, California 94305
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Washington, District of Columbia
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Wynnewood, Pennsylvania 19096
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