A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk" (NCT06374797) | Clinical Trial Compass
Active — Not RecruitingPhase 2
A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
United States150 participantsStarted 2024-07-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30
✕. 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.