Phase 3 Study of Reltecimod vs Placebo in Patients With Sepsis-associated Acute Kidney Injury

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Acute Kidney Injury, Peritonitis, Necrotizing Soft Tissue Infection

In brief

Phase 3 multicenter study to be conducted in up to 90 qualified participating sites globally to assess the efficacy and safety of Reltecimod vs placebo in patients with sepsis-associated Stage 2/3 AKI.

Key facts

Study ID: NCT03403751
Run by: Atox Bio Ltd
People needed: 58
Starts: 2018-05-24
Expected to finish: 2019-12-14
Last updated by the study team: 2021-10-12

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
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.
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

You may not qualify if…

Has known prior history of chronic kidney disease (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
Patients receiving renal replacment therapy (RRT) for CKD
. Previously diagnosed with documented AKI in the last 30 days
Documented primary glomerular disease or toxic tubulo-interstitial nephritis at the time of AKI diagnosis
Patient is not expected to survive throughout 28 days of study due to significant underlying medical condition
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 - Global Initiative for Chronic Obstructive Lung Disease - stage 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
Patient has acute pancreatitis with no established source of infection, uncomplicated appendicitis, or cholangitis or cholecystitis without peritonitis;
Pregnant or lactating women
Concurrent or previous enrollment in a clinical trial involving investigational drug or a medical device

Where it is running

Banner University Medical Center — Tucson, Arizona, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Loma Linda University Medical Center — Loma Linda, California, United States
University of California, Davis Medical Center — Sacramento, California, United States
UCSD Medical Center — San Diego, California, United States
Harbor-UCLA Medical Center — Torrance, California, United States
UCH-Memorial Health System — Colorado Springs, Colorado, United States
University of Colorado Hospital — Denver, Colorado, United States
Yale New Haven Hospital — New Haven, Connecticut, United States
Washington Hospital Center — Washington D.C., District of Columbia, United States
UF Health Shands Hospital — Gainesville, Florida, United States
University of Iowa Hospital and Clinics — Iowa City, Iowa, United States
University of Kentucky — Lexington, Kentucky, United States
LSU Health Science Center — New Orleans, Louisiana, United States
University of Maryland, Baltimore — Baltimore, Maryland, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Brigham and Women's Hospital — Boston, Massachusetts, United States
University of Michigan — Ann Arbor, Michigan, United States
Henry Ford Health System — Detroit, Michigan, United States
Fairview Southdale Hospital — Edina, Minnesota, United States
Hennepin County Medical Center — Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview — Minneapolis, Minnesota, United States
University of Missouri — Columbia, Missouri, United States
Capital Health System, Inc. — Trenton, New Jersey, United States
Maricopa Medical Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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