Auxora for Acute Kidney Injury

(KOURAGE Trial)

Recruiting at 35 trial locations

Overseen By Andrew Cunningham, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: CalciMedica, Inc.

Must not be taking: Chemotherapy, Immunosuppressants

Disqualifiers: Chronic lung disease, Organ transplant, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 36

Duration: 1 week

150 Participants Needed

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. ^{1 2 3 4 5}

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

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.

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

Group I: Auxora Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Currently, there are no specific therapies approved for the prevention or treatment of acute kidney injury (AKI), and traditional care remains largely supportive.

Recent research has identified various potential compounds targeting different pathways involved in AKI, such as oxidative stress and inflammation, which are now entering early-phase clinical trials, showing promise for future treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New drugs for acute kidney injury. Côté, JM., Murray, PT., Rosner, MH.[2021]

Acute kidney injury (AKI) is increasingly common in hospitalized patients and is linked to high rates of illness and death, yet current treatments, including loop diuretics, have not shown significant benefits in improving outcomes.

The management of AKI remains primarily supportive, as no interventions, including other diuretics and natriuretic agents, have convincingly demonstrated effectiveness in preventing or treating this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diuretics in acute kidney injury. Nigwekar, SU., Waikar, SS.[2022]

References

1. Spain pubmed.ncbi.nlm.nih.gov

[Acute kidney injury]. [2019]

2. France pubmed.ncbi.nlm.nih.gov

[Acute kidney injury: from concept to practice]. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

New drugs for acute kidney injury. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Diuretics in acute kidney injury. [2022]