Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" with the Lung: a Randomized Control Trial (KOURAGE)

Description

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.This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have associated AHRF. The definition of AKI and the stages of AKI will be based on the classification system proposed by the Acute Kidney Injury Working Group of Kidney Disease: Improving Global Outcomes (KDIGO) and incorporate both serum creatinine and urine volume criteria. AHRF will be defined as a P/F ≤ 300 that has been determined by either an arterial blood gas or imputed from the oxygen saturation (SpO2) recorded using pulse oximetry and is being treated with high flow nasal cannula with minimum flow rate

Trial Eligibility

Inclusion Criteria: 1. The patient is ≥ 18 years of age. 2. The patient has developed Stage 2 or Stage 3 AKI. 3. 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, and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation. 4. 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. 5. 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. 6. The patient is willing and able to, or has a LAR who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol. Exclusion Criteria: 1. The patient has a do not resuscitate or do not intubate directive. 2. 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. 3. The patient has been hospitalized for more than 7 days. 4. The patient has catecholamine resistant shock and has required ≥ 0.2 ug/kg/min of norepinephrine or equivalent for the prior 6 hours. 5. The patient has been receiving invasive mechanical ventilation for \> 72 hours. 6. The patient is receiving invasive mechanical ventilation and has had a FiO2 ≥ 80% documented in the previous 6 hours. 7. The patient is receiving ECMO. 8. The patient has started, or is expected to start KRT in the next 12 hours. 9. The patient has a serum triglyceride level ≥ 500 mg/dL. 10. 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. 11. 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. 12. The patient has a known history of an organ transplant. 13. The patient has a known history of HIV infection. 14. The patient has known history of hepatitis B infection. 15. The patient is currently receiving chemotherapy. 16. The patient is currently receiving immunosuppressive medications 17. The patient is known to be pregnant or is currently nursing. 18. The patient is allergic to eggs. 19. The patient is currently participating in another study of an investigational drug

Study Info

Interventions

Locations Recruiting

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