A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"

About

Brief Summary

Approximately 150 patients with acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF) will be randomized at up to 40 sites. Patients will be randomly assigned to either Auxora or matching placebo. Study drug infusions will occur every 24 hours for five consecutive days for a total of five infusions.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 2

Eligibility

Gender

All

Healthy Volunteers

No

Minimum Age

18 Years

Maximum Age

N/A

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 inspired oxygen [FiO2] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload
The patient is being treated with either high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation at time of randomization.
A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug.
A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug. A male patient must not donate sperm for 30 days after 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 cooperate with all aspects of the protocol.

Exclusion Criteria:

The patient has a do not intubate directive.
The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of non-invasive mechanical ventilation 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 urinary tract 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