Auxora for Acute Kidney Injury

(KOURAGE Trial)

Recruiting at 37 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Auxora for individuals with acute kidney injury (AKI) and breathing difficulties due to low oxygen levels. The goal is to determine if Auxora can improve kidney function compared to a placebo (a substance with no active medicine). Participants will receive infusions for five days. This trial may suit those diagnosed with severe AKI who require special oxygen support, such as a breathing machine. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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.

Is there any evidence suggesting that Auxora is likely to be safe for humans?

Research shows that Auxora has been tested in patients with severe acute kidney injury (AKI). In these studies, researchers closely monitored Auxora's safety and patient tolerance. Most patients in earlier trials tolerated the treatment well. Some side effects were reported, but they were considered manageable.

Auxora is administered through infusions, delivering it directly into the bloodstream over a few days. This method allows doctors to control the dose and monitor safety. While these studies are ongoing, the current phase suggests a clearer picture of Auxora's safety, and more data will help confirm its safety for patients with AKI. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for acute kidney injury that mainly focus on supportive care like dialysis and managing fluid balance, Auxora offers a new approach by targeting cellular stress responses. Auxora is unique because it acts on calcium overload in cells, which is a key factor in kidney injury. Researchers are excited about Auxora because it has the potential to directly reduce kidney damage at the cellular level, potentially improving outcomes more effectively and quickly than existing treatments.

What evidence suggests that Auxora might be an effective treatment for acute kidney injury?

Research has shown that Auxora, which participants in this trial may receive, might help treat severe acute kidney injury (AKI) with breathing problems. One study found that patients who took Auxora had a 62.7% lower chance of dying within 30 days compared to those who received a placebo, and this benefit lasted up to 60 days. These results suggest that Auxora could lower the risk of death for patients with these conditions. While more research is needed, these findings offer hope that Auxora could assist those dealing with AKI and respiratory issues. ^{1 2 3 6 7}

Who Is on the Research Team?

Sudarshan Hebbar, MD, Chief Medical Officer

Principal Investigator

CalciMedica, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. calcimedica.com calcimedica.com/kidney/

Acute Kidney Injury Auxora™ has the potential to treat severe acute kidney injury (AKI) with respiratory failure and limit morbidity and mortality associated with this disorder ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06374797

NCT06374797 | A Study of Auxora in Patients With AKI and ... This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40489964/

Design and Rationale of the KOURAGE Study a ... The KOURAGE trial will investigate the safety and efficacy of Auxora in patients with severe AKI and AHRF.

4. clinicaltrialsarena.com clinicaltrialsarena.com/news/calcimedica-telperian-auxora-trial-analysis/

CalciMedica and Telperian team up for Auxora trial analysis Auxora has been assessed in efficacy trials ... acute kidney injury accompanied by respiratory failure, with results anticipated in early 2026.

5. firstwordpharma.com firstwordpharma.com/story/5939587

CalciMedica Presents AKI Data from a Post-Hoc Analysis ... Patients treated with Auxora showed a 62.7% relative reduction versus placebo in mortality at day 30 which persisted through day 60. 7 out of 15 ...

6. ir.calcimedica.com ir.calcimedica.com/news-releases/news-release-details/calcimedica-announces-publication-american-journal-nephrology

Press Release KOURAGE is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Auxora in patients with severe acute kidney injury (AKI) ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06374797/a-study-of-auxora-in-patients-with-aki-and-injurious-lung-crosstalk

A Study of Auxora in Patients With AKI and Injurious Lung " ... This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe ...