150 Participants Needed

Auxora for Acute Kidney Injury

(KOURAGE Trial)

Recruiting at 35 trial locations
KR
AC
Overseen ByAndrew Cunningham, MD
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Auxora is unique because it is being specifically studied for acute kidney injury, a condition with limited effective drug treatments, and it may offer a novel approach compared to traditional supportive care and diuretics, which have not shown convincing benefits in clinical studies.12345

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

SH

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

My kidney injury is moderate to severe.
My oxygen levels have been low in the last 24 hours, and I need high-level oxygen support.
I, or my legal representative, agree to participate and follow the study rules.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either Auxora or placebo infusions every 24 hours for five consecutive days

1 week
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days
Daily assessments until Day 30 or discharge

Extended Follow-up

Participants are assessed for long-term outcomes at Day 90

60 days
1 visit (in-person or virtual) at Day 90

Treatment Details

Interventions

  • Auxora
Trial Overview 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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AuxoraExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Auxora is already approved in United States for the following indications:

🇺🇸
Approved in United States as Auxora for:
  • 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

Trials
8
Recruited
730+

Findings from Research

Acute kidney injury (AKI) affects 7% of hospitalized patients and up to 35% in intensive care, leading to increased mortality; early detection and differentiation of AKI types are crucial for effective management.
Preventive measures include maintaining adequate circulation and avoiding nephrotoxins, while treatment focuses on correcting underlying causes, monitoring electrolytes, and using protective agents to mitigate kidney damage.
[Acute kidney injury].Monedero, P., García-Fernández, N., Pérez-Valdivieso, JR., et al.[2019]
The term 'Acute Kidney Injury' (AKI) has replaced 'Acute Renal Failure', and the classification of AKI has evolved to include three stages to better detect moderate cases, especially in ICU patients where over 30% are affected.
Management strategies for AKI emphasize optimal resuscitation and hydration to prevent contrast-induced nephropathy, while the effectiveness of loop diuretics and low-dose dopamine remains unproven, highlighting the need for further research on renal replacement therapy and dialysis protocols.
[Acute kidney injury: from concept to practice].Moonen, M., Fraipont, V., Radermacher, L., et al.[2011]
In a study of 33,648 patients who underwent major surgery, the use of diuretics postoperatively was linked to nearly double the odds of developing acute kidney injury (AKI), while ACE inhibitors/angiotensin receptor blockers (ACEI/ARBs) showed a protective effect after cardiac surgery.
NSAIDs did not significantly increase the risk of AKI overall, but their use was associated with higher odds of AKI shortly after initial exposure, highlighting the importance of monitoring medication use in the postoperative period.
Angiotensin-Converting Enzyme Inhibitor/Receptor Blocker, Diuretic, or Nonsteroidal Anti-inflammatory Drug Use After Major Surgery and Acute Kidney Injury: A Case-Control Study.Roberts, DJ., Smith, SA., Tan, Z., et al.[2021]

References

[Acute kidney injury]. [2019]
[Acute kidney injury: from concept to practice]. [2011]
Angiotensin-Converting Enzyme Inhibitor/Receptor Blocker, Diuretic, or Nonsteroidal Anti-inflammatory Drug Use After Major Surgery and Acute Kidney Injury: A Case-Control Study. [2021]
New drugs for acute kidney injury. [2021]
Diuretics in acute kidney injury. [2022]
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