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Treatment of Acute Kidney Injury with Auxora

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

Phase 2 Interventional CalciMedica, Inc. · NCT06374797

This study is testing if a new treatment called Auxora can help people with severe kidney injury and breathing problems feel better and recover faster.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years and up
SexAll
SponsorCalciMedica, Inc. Industry-sponsored
Drugs / interventionschemotherapy
Locations36 sites (Birmingham, Alabama and 35 other locations)
Trial IDNCT06374797 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the efficacy, safety, and tolerability of Auxora in patients suffering from severe acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF). Approximately 150 patients will be randomized to receive either Auxora or a matching placebo over five consecutive days. The study employs a double-blind, placebo-controlled design, with randomization stratified by the use of invasive mechanical ventilation and the severity of AKI. The trial aims to assess the impact of Auxora on patient outcomes related to kidney function and respiratory health.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with Stage 2 or Stage 3 AKI and associated AHRF requiring respiratory support.

Not a fit: Patients with AKI not associated with AHRF or those with cardiogenic pulmonary edema may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve kidney function and respiratory outcomes in patients with severe AKI and AHRF.

How similar studies have performed: Other studies have explored treatments for AKI, but the specific use of Auxora in this context is novel.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Birmingham, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Kidney InjuryAKIAuxora
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.