Auxora for Acute Kidney Injury
(KOURAGE Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving chemotherapy or immunosuppressive medications, you would not be eligible to participate.
What makes the drug Auxora unique for treating acute kidney injury?
What is the purpose of this trial?
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.
Research Team
Sudarshan Hebbar, MD, Chief Medical Officer
Principal Investigator
CalciMedica, Inc.
Eligibility Criteria
This trial is for adults over 18 with Stage 2 or Stage 3 Acute Kidney Injury (AKI) and severe lung issues needing high oxygen. They must agree to use birth control during the study and not donate sperm or eggs. People can't join if they have heart-related lung problems.Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Auxora or placebo infusions every 24 hours for five consecutive days
Follow-up
Participants are monitored for safety and effectiveness after treatment
Extended Follow-up
Participants are assessed for long-term outcomes at Day 90
Treatment Details
Interventions
- Auxora
Auxora is already approved in United States for the following indications:
- Acute kidney injury (AKI) associated with acute hypoxemic respiratory failure (AHRF)
Find a Clinic Near You
Who Is Running the Clinical Trial?
CalciMedica, Inc.
Lead Sponsor