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Anti-inflammatory

Auxora for Acute Kidney Injury (KOURAGE Trial)

Phase 2
Recruiting
Research Sponsored by CalciMedica, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient has developed Stage 2 or Stage 3 AKI.
The patient is ≥ 18 years of age.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up sfisd through day 30

Summary

This trial will involve 150 patients with kidney injury and respiratory failure at 40 sites. The patients will be randomly assigned to receive either Auxora or a placebo for five days through infusions every

Who is the study for?
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.
What is being tested?
The study tests Auxora against a placebo in patients with AKI and acute hypoxemic respiratory failure. Participants will receive either Auxora or placebo every day for five days, randomly assigned at up to 40 locations.
What are the potential side effects?
Possible side effects of Auxora are not detailed here but typically could include reactions at the infusion site, changes in blood pressure, kidney function alterations, immune responses, or other drug-specific effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney injury is moderate to severe.
Select...
I am 18 years old or older.
Select...
My oxygen levels have been low in the last 24 hours, and I need high-level oxygen support.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~sfisd through day 30
This trial's timeline: 3 weeks for screening, Varies for treatment, and sfisd through day 30 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AuxoraExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Auxora
2020
Completed Phase 2
~290

Find a Location

Who is running the clinical trial?

CalciMedica, Inc.Lead Sponsor
7 Previous Clinical Trials
579 Total Patients Enrolled
Sudarshan Hebbar, MD, Chief Medical OfficerStudy DirectorCalciMedica, Inc.
~81 spots leftby Aug 2025
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