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

Launched by CALCIMEDICA, INC. · Apr 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Auxora for patients who have acute kidney injury (AKI) related to severe lung problems. The goal is to see if Auxora can help improve kidney function in patients who are experiencing acute hypoxemic respiratory failure, which means their lungs are not providing enough oxygen to the body. About 150 patients will take part in the trial at various sites, and they will be randomly assigned to receive either Auxora or a placebo (a treatment that looks the same but has no active ingredients). Participants will receive the treatment through an infusion once a day for five days.

To qualify for this study, participants must be at least 18 years old and have developed Stage 2 or Stage 3 AKI. They also need to have specific lung conditions that require high-flow oxygen support. Patients who have certain medical issues, like chronic lung disease or those who are pregnant or nursing, cannot participate. Throughout the study, participants will be closely monitored for their health and response to the treatment. This trial is currently recruiting, so if you or someone you know might be eligible, it could be an opportunity to contribute to important research while receiving care.

Gender

ALL

Eligibility criteria

• 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
• • 4. 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.
• • 5. 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.
• • 6. 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.
• • 7. 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:
• • 1. The patient has a 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 in the ICU for more than 10 days.
• • 4. The patient has been receiving invasive mechanical ventilation for \> 120 hours.
• • 5. The patient is receiving extracorporeal membrane oxygen (ECMO).
• • 6. The patient has started or is planned to start kidney replacement therapy (KRT) before randomization.
• • 7. The patient has a serum triglyceride level ≥ 500 mg/dL.
• • 8. 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.
• • 9. 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.
• • 10. The patient has a known history of an organ transplant.
• • 11. The patient has a known history of HIV infection.
• • 12. The patient has known history of hepatitis B infection.
• • 13. The patient is currently receiving chemotherapy.
• • 14. The patient is currently receiving immunosuppressive medications
• • 15. The patient is known to be pregnant or is currently nursing.
• • 16. The patient is allergic to eggs.
• • 17. The patient is currently participating in another study of an investigational drug