Phase 2 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hospital, Hospital, Gastrointestinal
Therapuetic Areas:Gastroenterology, Nephrology / Urology, Other
Healthy:No
Age Range:18 - 80
Updated:11/3/2018
Start Date:May 24, 2018
End Date:March 2020
Contact:David Wilfret, MD
Email:davidw@atoxbio.com
Phone:919 439-3400

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Phase 2 Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Reltecimod as Compared to Placebo in Addition to Standard of Care in Patients With Sepsis-associated Acute Kidney Injury (SA-AKI)

Phase 2 multicenter study to be conducted in up to 50 qualified participating sites in the
United States to assess the efficacy and safety of Reltecimod vs placebo in patients with
abdominal sepsis-associated Stage 2/3 AKI.

Phase 2 randomized, placebo controlled study assessing the efficacy (complete recovery from
AKI) and safety of Reltecimod in patients with suspected or confirmed abdominal sepsis
(planned or completed surgical (laparotomy or laparoscopy) or interventional radiologic
procedures for control of underlying abdominal infection within 24 hours of evaluation by
medical personnel), requiring intensive care unit (ICU) or step down unit admission and in
whom the diagnosis of Stage 2/3 acute kidney injury (AKI; as defined by Kidney Disease
Improving Global Outcomes (KDIGO) criteria) is established at initial presentation for
medical evaluation or up to 48 hours from the suspected diagnosis of abdominal sepsis.

Inclusion Criteria:

1. Has either suspected or documented diagnosis of abdominal sepsis requiring treatment
with parenteral antibiotics and planned or completed surgical (laparotomy or
laparoscopy) or interventional radiologic procedures within 24 hours of evaluation by
medical personnel. Recommended surgical or interventional radiologic procedures be
performed with 12 hours of evaluation by medical personnel.

2. Initial diagnosis of AKI Stage 2 or 3 according to KDIGO AKI criteria established
either upon presentation to medical care in those patients with suspected abdominal
sepsis or in those patients in whom the initial diagnosis of AKI is established during
the 48 hour period from the suspected diagnosis of abdominal sepsis.

3. Study medication must be administered within 6 hours of confirmation of onset of Stage
2 or 3 AKI as established at the study site, under the following criteria:

- After the decision is made by the attending surgeon at the study site for a
surgical or interventional radiology procedure for the abdominal infection OR

- After confirmed diagnosis of abdominal infection has been established by a
surgical or interventional radiology procedure

Exclusion Criteria:

1. Has known prior history of CKD with a documented estimated GFR (eGFR) < 30 mL/min

• Exception: Patients with history of CKD but no available prior eGFR who have
documented normal kidney size on ultrasound or computed tomography evaluation
(performed within 90 days of screening) will be eligible

2. Patients receiving RRT for chronic kidney disease

3. Patients that are treated with RRT for acute kidney dysfunction, starting prior to
study drug administration or in whom there is an immediate plan to initiate RRT upon
diagnosis of AKI

4. Previously diagnosed with documented AKI in the last 30 days

5. Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the
time of AKI diagnosis

6. Patient is not expected to survive throughout 28 days of study due to significant
underlying medical condition

7. Any concurrent medical condition, which in the opinion of the Investigator, may
compromise the safety of the patient or the objectives of the study or the patient
will not benefit from treatment such as:

- Congestive heart failure (CHF) {New York Heart Association (NYHA) class III-IV}

- Severe chronic obstructive pulmonary disease (COPD) {GOLD stage III-IV. or
chronic hypoxemia

- Liver dysfunction {Childs-Pugh class C}

- Primary or acquired immunodeficiency or immunosuppression due to treatment with
immunosuppressive medications

- Known HIV infection with CD4 count < 200 cells/mm3 or < 14% of all lymphocytes

- Neutropenia < 1,000 cells/mm3 not due to the underlying infection

- Receiving or about to receive chemotherapy or biologic anti-cancer treatment,

- Hematological and lymphatic malignancies in the last 5 years

8. Patient has acute pancreatitis with no established source of infection, uncomplicated
appendicitis, or cholangitis or cholecystitis without peritonitis;

9. Pregnant or lactating women

10. Concurrent or previous enrollment in a clinical trial involving investigational drug
or a medical device
We found this trial at
35
sites
Minneapolis, Minnesota 55414
Principal Investigator: Frederick Endorf, MD
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621 West Lombard Street
Baltimore, Maryland 21201
(410) 706-7101
Principal Investigator: Jose Diaz, MD
University of Maryland, Baltimore Welcome to the University of Maryland, Baltimore (UMB) founded in 1807...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Peter Fagenholz, MD
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Principal Investigator: Reza Askari, MD
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
Principal Investigator: John Green, MD
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Charlotte, NC
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529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: Kevin Sexton, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Principal Investigator: Arvin Gee, MD
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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4502 Medical Drive
San Antonio, Texas 78284
(210) 567-7000
Principal Investigator: Christopher Crane, MD
University of Texas Health Science Center at San Antonio The University of Texas Health Science...
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
Principal Investigator: Pauline Park, MD
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Bethlehem, Pennsylvania
Principal Investigator: Stanislaw P Stawicki, MD
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Buffalo, New York 14215
Principal Investigator: William Flynn, MD
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Cincinnati, Ohio 45219
Principal Investigator: Michael Goodman, MD
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Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Jacob Quick, MD
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David Evans, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Dayton, Ohio 45409
Principal Investigator: Peter Ekeh, MD
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Detroit, Michigan 48202
Principal Investigator: Jeffrey Johnson, MD
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Fort Worth, Texas 76104
Principal Investigator: Rajesh Ghandi, MD
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Gainesville, Florida 32610
Principal Investigator: Scott Brakenridge, MD
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1001 E 5th St
Greenville, North Carolina 27858
(252) 328-6131
Principal Investigator: Mark Newell, MD
East Carolina University Whether it's meeting the demand for more teachers and healthcare professionals or...
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Hershey, Pennsylvania 17033
Principal Investigator: Melissa Boltz, MD
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Iowa City, Iowa 52242
Principal Investigator: Kent Choi, MD
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Lexington, Kentucky
859) 257-9000
Principal Investigator: Andrew Bernard, MD
University of Kentucky The University of Kentucky is a public, land grant university dedicated to...
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11234 Anderson St
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Richard Catalano, MD
Loma Linda University Medical Center An outgrowth of the original Sanitarium on the hill in...
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20 York St, N20 York St,
New Haven, Connecticut 06520
(203) 688-4242
Principal Investigator: Adrian Maung, MD
Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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New Orleans, Louisiana 70112
Principal Investigator: Patrick Greiffenstein, MD
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Philadelphia, Pennsylvania 19104
Principal Investigator: Niels Martin, MD
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1020 Walnut St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Joshua Marks, MD
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Phoenix, Arizona 85008
Principal Investigator: Kevin Foster, MD
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
Principal Investigator: Christine S Cocanour, MD
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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34800 Bob Wilson Drive
San Diego, California 92103
Principal Investigator: Leslie Kobayashi, MD
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Byrce Robinson, MD
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Staten Island, New York 10305
Principal Investigator: Stephen Cohn, MD
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Trenton, New Jersey 08638
Principal Investigator: Michael Kalina, MD
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Tucson, Arizona 85742
Principal Investigator: Lynn Gries, MD
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110 Irving St NW
Washington, District of Columbia 20010
(202) 877-7000
Principal Investigator: Christine Trankiem, MD
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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