Auxora for the Treatment of AKI and Modulation of Injurious

Research Study for Investigational Medication in Severe Acute Kidney Injury with Respiratory Failure

D
Damien G. Patel, MD

Primary Investigator

Not Recruiting
18 years - 100 years
All
Phase 2
1 participants needed
1 Location

Brief description of study

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. 

THIS STUDY IS ENROLLING BY INVITATION ONLY

Detailed description of study

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.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Acute Kidney Injury, AKI
  • Age: 18 years - 100 years
  • Gender: All

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

This study investigates the use of an investigational medication for patients with severe acute kidney injury (AKI) and associated acute hypoxemic respiratory failure (AHRF). AKI is a sudden decline in kidney function, while AHRF is a condition where the lungs cannot provide enough oxygen to the blood. The purpose of this study is to evaluate the effectiveness and safety of the investigational medication compared to a placebo.

Participants will be randomly assigned to receive either the investigational medication or a placebo. The study involves drug infusions given every 24 hours for five consecutive days. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.

  • Who can participate: Adults aged 18 and older with Stage 2 or Stage 3 AKI and specific respiratory criteria can participate. Participants must agree to use birth control if of childbearing potential and be able to provide informed consent.
  • Study details: Participants will receive infusions of the investigational medication or placebo every 24 hours for five days. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine.
Updated on 14 Jan 2026. Study ID: ECRO-CALCIMEDICA-KOURAGE, 24967

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