Phase
Condition
Kidney Disease
Kidney Failure
Renal Failure
Treatment
Auxora
Placebo
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The patient is ≥ 18 years of age.
The patient has developed Stage 2 or Stage 3 AKI.
The patient has a documented partial pressure of oxygen [Pa02]/fraction of inspiredoxygen [FiO2] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 orobtained from an arterial blood gas, that is not explained by cardiogenic pulmonaryedema or volume overload
The patient is being treated with either high flow nasal cannula with minimum flowrate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanicalventilation at time of randomization.
A female patient of childbearing potential who is sexually active with a malepartner is willing to practice acceptable methods of birth control for 30 days afterthe last dose of study drug.
A male patient who is sexually active with a female partner of childbearingpotential is willing to practice acceptable methods of birth control for 30 daysafter the last dose of study drug. A male patient must not donate sperm for 30 daysafter the last dose of study drug.
The patient is willing and able to, or has a legally authorized representative (LAR)who is willing and able to, provide informed consent to participate and to cooperatewith all aspects of the protocol.
Exclusion
Exclusion Criteria:
The patient has a do not intubate directive.
The patient has chronic lung disease that requires supplemental non-invasive oxygenas an outpatient or home mechanical ventilation. The use of non-invasive mechanicalventilation to treat obstructive sleep apnea is not an exclusion.
The patient has been hospitalized in the ICU for more than 10 days.
The patient has been receiving invasive mechanical ventilation for > 120 hours.
The patient is receiving extracorporeal membrane oxygen (ECMO).
The patient has started or is planned to start kidney replacement therapy (KRT)before randomization.
The patient has a serum triglyceride level ≥ 500 mg/dL.
The patient has a direct bilirubin level >3.0 mg/dL or both a direct bilirubin level ≥ 2.0 mg/dL and an international normalized ratio (INR) ≥ 1.7.
AKI is suspected to be secondary to: renal artery or renal vein thrombosis;hepato-renal syndrome; cholesterol emboli syndrome; acute glomerulonephritis;vasculitis; acute allergic interstitial nephritis; intrarenal or extrarenal urinarytract obstruction; use of immune checkpoint inhibitor.
The patient has a known history of an organ transplant.
The patient has a known history of HIV infection.
The patient has known history of hepatitis B infection.
The patient is currently receiving chemotherapy.
The patient is currently receiving immunosuppressive medications
The patient is known to be pregnant or is currently nursing.
The patient is allergic to eggs.
The patient is currently participating in another study of an investigational drug
Study Design
Study Description
Connect with a study center
University of Alabama
Birmingham, Alabama 35249
United StatesActive - Recruiting
Chandler Regional Hospital
Chandler, Arizona 85224
United StatesActive - Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesActive - Recruiting
UCLA
Los Angeles, California 90095
United StatesActive - Recruiting
Stanford Health Care
Stanford, California 94304
United StatesActive - Recruiting
Lundquist Institute for Biomedical Innovation at UCLA-Harbor Medical Center
Torrance, California 90509
United StatesSite Not Available
Torrance Memorial
Torrance, California 90502
United StatesActive - Recruiting
Torrance Memorial Medical Center
Torrance, California 90502
United StatesActive - Recruiting
University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
Medstar Washington Hospital Center
Washington, District of Columbia 20010
United StatesSite Not Available
Medstar Washington Hospital Center
Washington DC, District of Columbia 20010
United StatesSite Not Available
Sarasota Memorial
Sarasota, Florida 34239
United StatesSite Not Available
Tampa General
Tampa, Florida 33606
United StatesActive - Recruiting
Emory Johns Creek Hospital
Johns Creek, Georgia 30097
United StatesActive - Recruiting
St Luke's Hospital
Boise, Idaho 83712
United StatesActive - Recruiting
St Luke's Hospital
Boise, Idaho 83712
United StatesActive - Recruiting
Northwestern University-Pulmonary & Critical Care Medicine
Chicago, Illinois 60611
United StatesActive - Recruiting
University of Indiana
Indianapolis, Indiana 46202
United StatesActive - Recruiting
University of Iowa
Iowa City, Iowa 52243
United StatesActive - Recruiting
University of Maryland
Baltimore, Maryland 21201
United StatesSite Not Available
Brigham & Woman's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
University of Michigan
Ann Arbor, Michigan 48109
United StatesSite Not Available
Henry Ford
Detroit, Michigan 48202
United StatesActive - Recruiting
My Michigan Health
Midland, Michigan 48670
United StatesActive - Recruiting
Regions Hospital
Saint Paul, Minnesota 55101
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65212
United StatesActive - Recruiting
Hannibal Regional
Hannibal, Missouri 63401
United StatesActive - Recruiting
NYU Langone Health - Brooklyn
Brooklyn, New York 11220
United StatesActive - Recruiting
Northshore University Hospital
New Hyde Park, New York 11042
United StatesActive - Recruiting
Northwell Health - North Shore University Hospital
New Hyde Park, New York 11042
United StatesSite Not Available
NYU Langone Health - Bellview
New York, New York 10016
United StatesActive - Recruiting
NYU Langone Health - Tisch Hospital
New York, New York 10016
United StatesActive - Recruiting
Long Island Jewish Medical Center
Queens, New York 11040
United StatesSite Not Available
Stony Brook University Hospital
Stony Brook, New York 11794
United StatesActive - Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesActive - Recruiting
The Ohio State University
Columbus, Ohio 43202
United StatesActive - Recruiting
Temple University
Philadelphia, Pennsylvania 19140
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
UT Houston
Houston, Texas 77030
United StatesActive - Recruiting
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
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