Phase
Condition
Kidney Failure
Kidney Disease
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 StatesSite Not Available
Chandler Regional Hospital
Chandler, Arizona 85224
United StatesSite Not Available
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United StatesSite Not Available
UCLA
Los Angeles, California 90095
United StatesSite Not Available
Stanford Health Care
Stanford, California 94304
United StatesSite Not Available
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 StatesSite Not Available
Lundquist Institute for Biomedical Innovation at UCLA-Harbor Medical Center
Torrance 5403022, California 5332921 90509
United StatesSite Not Available
University of Colorado Hospital
Aurora, Colorado 80045
United StatesSite Not Available
Tampa General
Tampa, Florida 33606
United StatesSite Not Available
Emory Johns Creek Hospital
Johns Creek, Georgia 30097
United StatesSite Not Available
St Luke's Hospital
Boise, Idaho 83712
United StatesActive - Recruiting
St Luke's Hospital
Boise, Idaho 83712
United StatesSite Not Available
Northwestern University-Pulmonary & Critical Care Medicine
Chicago, Illinois 60611
United StatesSite Not Available
University of Indiana
Indianapolis, Indiana 46202
United StatesSite Not Available
University of Iowa
Iowa City, Iowa 52243
United StatesSite Not Available
Brigham & Woman's Hospital
Boston, Massachusetts 02115
United StatesSite Not Available
Brigham & Women's Hospital
Boston, Massachusetts 02115
United StatesActive - Recruiting
Lahey Hospital and Medical Center
Burlington, Massachusetts 01805
United StatesSite Not Available
Henry Ford
Detroit, Michigan 48202
United StatesSite Not Available
My Michigan Health
Midland, Michigan 48670
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65212
United StatesSite Not Available
Hannibal Regional
Hannibal, Missouri 63401
United StatesSite Not Available
Holy Name
Teaneck, New Jersey 07666
United StatesSite Not Available
NYU Langone Health - Brooklyn
Brooklyn, New York 11220
United StatesSite Not Available
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 StatesSite Not Available
NYU Langone Health - Tisch Hospital
New York, New York 10016
United StatesSite Not Available
NYU Langone Health - Tisch Hospital
New York 5128581, New York 5128638 10016
United StatesSite Not Available
Cleveland Clinic Akron General
Akron, Ohio 44307
United StatesSite Not Available
Cleveland Clinic
Cleveland, Ohio 44095
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesSite Not Available
The Ohio State University
Columbus, Ohio 43202
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland 5150529, Ohio 5165418 44106
United StatesSite Not Available
Geisinger Medical Center
Danville, Pennsylvania 17822
United StatesSite Not Available
Temple University
Philadelphia, Pennsylvania 19140
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
Baylor Scott and White Research Institute
Dallas, Texas 75246
United StatesSite Not Available
Houston Methodist
Houston, Texas 77030
United StatesSite Not Available
UT Houston
Houston, Texas 77030
United StatesSite Not Available
Houston Methodist
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available

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