Acute Kidney InjuryPhase 2KOURAGENCT06374797
A Study of Auxora in Patients With AKI and Injurious Lung "Crosstalk"
A Phase 2 study testing Auxora in people with Acute Kidney Injury, run by CalciMedica, Inc. at 33 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Auxora
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 33 sitesUnited States
- Study dates
- 1 Jul 2024to 6 Apr 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is ≥ 18 years of age.
- The patient has developed Stage 2 or Stage 3 AKI.
- The patient has a documented partial pressure of oxygen [Pa02]/fraction of inspired oxygen [FiO2] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload
- The patient is being treated with either high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation at time of randomization.
- A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug.
- A male patient who is sexually active with a female partner of childbearing potential is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug. A male patient must not donate sperm for 30 days after the last dose of study drug.
- The patient is willing and able to, or has a legally authorized representative (LAR) who is willing and able to, provide informed consent to participate and to cooperate with all aspects of the protocol.
Who cannot join
- The patient has a do not intubate directive.
- The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of non-invasive mechanical ventilation to treat obstructive sleep apnea is not an exclusion.
- The patient has been hospitalized in the ICU for more than 10 days.
- The patient has been receiving invasive mechanical ventilation for > 120 hours.
- The patient is receiving extracorporeal membrane oxygen (ECMO).
- The patient has started or is planned to start kidney replacement therapy (KRT) before randomization.
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- The patient has a serum triglyceride level ≥ 500 mg/dL.
- The patient has a direct bilirubin level >3.0 mg/dL or both a direct bilirubin level ≥ 2.0 mg/dL and an international normalized ratio (INR) ≥ 1.7.
- AKI is suspected to be secondary to: renal artery or renal vein thrombosis; hepato-renal syndrome; cholesterol emboli syndrome; acute glomerulonephritis; vasculitis; acute allergic interstitial nephritis; intrarenal or extrarenal urinary tract obstruction; use of immune checkpoint inhibitor.
- The patient has a known history of an organ transplant.
- The patient has a known history of HIV infection.
- The patient has known history of hepatitis B infection.
- The patient is currently receiving chemotherapy.
- The patient is currently receiving immunosuppressive medications
- The patient is known to be pregnant or is currently nursing.
- The patient is allergic to eggs.
- The patient is currently participating in another study of an investigational drug
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Cleveland Clinic Akron General
Akron, Ohio, 44307
University of Colorado Hospital
Aurora, Colorado, 80045
University of Alabama
Birmingham, Alabama, 35249
St Luke's Hospital
Boise, Idaho, 83712
Brigham & Woman's Hospital
Boston, Massachusetts, 02115
NYU Langone Health - Brooklyn
Brooklyn, New York, 11220
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Chandler Regional Hospital
Chandler, Arizona, 85224
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia
Charlottesville, Virginia, 22903
Northwestern University-Pulmonary & Critical Care Medicine
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44095
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
University of Missouri
Columbia, Missouri, 65212
The Ohio State University
Columbus, Ohio, 43202
Baylor Scott and White Research Institute
Dallas, Texas, 75246
Geisinger Medical Center
Danville, Pennsylvania, 17822
Henry Ford
Detroit, Michigan, 48202
Hannibal Regional
Hannibal, Missouri, 63401
UT Houston
Houston, Texas, 77030
University of Indiana
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52243
Emory Johns Creek Hospital
Johns Creek, Georgia, 30097
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
UCLA
Los Angeles, California, 90095
My Michigan Health
Midland, Michigan, 48670
NYU Langone Health - Bellview
New York, New York, 10016
NYU Langone Health - Tisch Hospital
New York, New York, 10016
Temple University
Philadelphia, Pennsylvania, 19140
Stanford Health Care
Stanford, California, 94304
Tampa General
Tampa, Florida, 33606
Holy Name
Teaneck, New Jersey, 07666
Torrance Memorial Medical Center
Torrance, California, 90502
About this study
Official title: Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" With the Lung: A Randomized Control Trial (KOURAGE)
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.
Read the detailed description
This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have associated AHRF. The definition of AKI and the stages of AKI will be based on the classification system proposed by the Acute Kidney Injury Working Group of Kidney Disease: Improving Global Outcomes (KDIGO) and incorporate both serum creatinine and urine volume criteria. AHRF will be defined as a P/F ≤ 300 that has been determined by either an arterial blood gas or imputed from the oxygen saturation (SpO2) recorded using pulse oximetry and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation. Approximately 150 patients with severe AKI, defined as having developed either stage 2 or 3 AKI at the time of consent, who have associated AHRF will be randomized 1:1 into either the Auxora or placebo group using a computer-generated randomization scheme accessed through an interactive voice/web response system (IXRS). Randomization will be stratified by the use of invasive mechanical ventilation and by Stage 3 AKI.
Patients who are randomized to the Auxora group will receive 1.25 mL/kg (2.0 mg/kg of zegocractin) IV over 4 hours at 0 hours and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. Patients who are randomized to the placebo group will receive 1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. Placebo will be a matching emulsion without the active pharmaceutical ingredient zegocractin. The sponsor, investigators, pharmacists, and patients will be blinded to the assigned group. The Start of First Infusion of Study Drug (SFISD) should occur no more than 24 hours of the patient or legally authorized representative (LAR) providing informed consent. A study physician or appropriately trained delegate will perform study-specific hospital assessments immediately prior to the SFISD, and then every 24 hours after the SFISD until 720 hours (Day 30), or until discharge if earlier. All patients, including those that are discharged from the hospital to home, or to a skilled nursing facility, or to an extended care facility, will be assessed at Day 90.
All AKI should be managed according to the KDIGO 2012 guidelines which recommends maintaining adequate organ perfusion, avoiding volume overload, avoiding hyperglycemia, discontinuing nephrotoxic agents, and adjusting dosing of renally excreted medications. AHRF/acute respiratory distress syndrome (ARDS) should be managed according to the 2023 European Society of Intensive Care Medicine (ESICM) major recommendations.
- Conditions
- Acute Kidney Injury
- Being tested
- Auxora, Placebo
- Keywords
- AKI, Acute Kidney Injury, Auxora
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AuxoraDrug
1.25 mL/kg (2.0 mg/kg of zegocractin) intravenously (IV) over 4 hours at 0 hours, and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72 and 96 hours for a total of 5 doses.
PlaceboDrug
1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses.
| Study group | Role | What they receive |
|---|---|---|
| Auxora | Experimental | Not described Receives: Drug: Auxora |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30
The primary efficacy analysis will apply the win ratio method and the Finkelstein-Schoenfeld method to the primary endpoints. The win ratio method allocates all Auxora and placebo pairs to the components that comprise the primary endpoint in a hierarchical fashion.
Categories (a) and (c) represent Auxora wins based on all-cause mortality and days ventilator-free and KRT-free. Similarly, categories (b) and (d) represent placebo wins. Category (e) represents ties.
(a) Death on placebo, but alive on Auxora at day 30 (b) Death on Auxora, but alive on placebo at day 30 (e) Death on placebo and death on Auxora at day 30
If alive on placebo and alive on Auxora at day 30:
(c) Greater number of days alive, ventilator-free and KRT-free on Auxora (d) Greater number of days alive, ventilator-free and KRT-free on Placebo (e) Equal number of days alive, ventilator-free and KRT-free We will calculate the overall win ratio by adding (a) + (c) and dividing it by the sum of (b) + (d).
Measured: SFISD through Day 30
Secondary outcomes (11)
Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days
Measured: At Day 90
MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days
Measured: At Day 90
Proportion of patients alive at Day 30
Measured: At Day 30
Proportion of patients alive at Day 90
Measured: Day 90
Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30
Measured: SFISD through Day 30
Days alive and KRT-free from SFISD through Day 30
Measured: SFISD through Day 30
Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale
The measurement tool is an 8-point ordinal scale: 1=Death; 2=Hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation(ECMO); 3=Hospitalized, requiring non-invasive ventilation or high flow supplemental oxygen; 4=Hospitalized, requiring low flow supplemental oxygen; 5=Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care; 6=Hospitalized, not requiring supplemental oxygen or ongoing medical care; 7=Discharged, requiring supplemental oxygen; 8=Discharged, not requiring supplemental oxygen
Measured: SFISD through Day 30
Proportion of patients receiving KRT at Day 30
Measured: At Day 30
Proportion of patients receiving KRT at Day 90
Measured: At Day 90
Number of patients with treatment-related adverse events (TEAE)
Measured: SFISD through Day 90
Number of patients with grade 3 TEAEs
Measured: SFISD through Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 Jul 2024
- Primary completion6 Apr 2026
- Study completion6 Apr 2026
Why it stopped: The study was stopped due to imbalance in randomization stratification of severe patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- CalciMedica, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudarshan Hebbar, MD, Chief Medical Officer, Study director, CalciMedica, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374797
- Sponsor's protocol ID
- CMZ-207
- Acronym
- KOURAGE
- Status last verified
- Aug 2026
- First submitted
- 16 Apr 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Auxora for the Treatment of AKI and Modulation of Injurious "Crosstalk" With the Lung: A Randomized Control Trial (KOURAGE)
- ClinicalTrials.gov ID
- NCT06374797
- Acronym / sponsor ID
- KOURAGE / CMZ-207
- Conditions
- Acute Kidney Injury
- Keywords
- AKI, Acute Kidney Injury, Auxora
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped due to imbalance in randomization stratification of severe patients.
- Enrolment
- 122 participants (actual)
- Lead sponsor
- CalciMedica, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 6 Apr 2026 (actual)
- Study completion
- 6 Apr 2026 (actual)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This double blind, randomized, placebo-controlled study will evaluate the efficacy, safety, and tolerability of Auxora in patients with severe AKI who have associated AHRF. The definition of AKI and the stages of AKI will be based on the classification system proposed by the Acute Kidney Injury Working Group of Kidney Disease: Improving Global Outcomes (KDIGO) and incorporate both serum creatinine and urine volume criteria. AHRF will be defined as a P/F ≤ 300 that has been determined by either an arterial blood gas or imputed from the oxygen saturation (SpO2) recorded using pulse oximetry and is being treated with high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation. Approximately 150 patients with severe AKI, defined as having developed either stage 2 or 3 AKI at the time of consent, who have associated AHRF will be randomized 1:1 into either the Auxora or placebo group using a computer-generated randomization scheme accessed through an interactive voice/web response system (IXRS). Randomization will be stratified by the use of invasive mechanical ventilation and by Stage 3 AKI.
Patients who are randomized to the Auxora group will receive 1.25 mL/kg (2.0 mg/kg of zegocractin) IV over 4 hours at 0 hours and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. Patients who are randomized to the placebo group will receive 1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. Placebo will be a matching emulsion without the active pharmaceutical ingredient zegocractin. The sponsor, investigators, pharmacists, and patients will be blinded to the assigned group. The Start of First Infusion of Study Drug (SFISD) should occur no more than 24 hours of the patient or legally authorized representative (LAR) providing informed consent. A study physician or appropriately trained delegate will perform study-specific hospital assessments immediately prior to the SFISD, and then every 24 hours after the SFISD until 720 hours (Day 30), or until discharge if earlier. All patients, including those that are discharged from the hospital to home, or to a skilled nursing facility, or to an extended care facility, will be assessed at Day 90.
All AKI should be managed according to the KDIGO 2012 guidelines which recommends maintaining adequate organ perfusion, avoiding volume overload, avoiding hyperglycemia, discontinuing nephrotoxic agents, and adjusting dosing of renally excreted medications. AHRF/acute respiratory distress syndrome (ARDS) should be managed according to the 2023 European Society of Intensive Care Medicine (ESICM) major recommendations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auxora | Experimental | Drug: Auxora |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient is ≥ 18 years of age.
- The patient has developed Stage 2 or Stage 3 AKI.
- The patient has a documented partial pressure of oxygen [Pa02]/fraction of inspired oxygen [FiO2] (P/F) ≤ 300 in the prior 24 hours, either imputed from SpO2 or obtained from an arterial blood gas, that is not explained by cardiogenic pulmonary edema or volume overload
- The patient is being treated with either high flow nasal cannula with minimum flow rate ≥ 30 liters/min, or non-invasive mechanical ventilation, or invasive mechanical ventilation at time of randomization.
- A female patient of childbearing potential who is sexually active with a male partner is willing to practice acceptable methods of birth control for 30 days after the last dose of study drug.
Key exclusion criteria (17 listed)
- The patient has a do not intubate directive.
- The patient has chronic lung disease that requires supplemental non-invasive oxygen as an outpatient or home mechanical ventilation. The use of non-invasive mechanical ventilation to treat obstructive sleep apnea is not an exclusion.
- The patient has been hospitalized in the ICU for more than 10 days.
- The patient has been receiving invasive mechanical ventilation for > 120 hours.
- The patient is receiving extracorporeal membrane oxygen (ECMO).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auxora1.25 mL/kg (2.0 mg/kg of zegocractin) intravenously (IV) over 4 hours at 0 hours, and then 1.0 mL/kg (1.6 mg/kg of zegocractin) IV over 4 hours at 24, 48, 72 and 96 hours for a total of 5 doses. | Drug | Auxora |
| Placebo1.25 mL/kg IV over 4 hours at 0 hours and then 1.0 mL/kg IV over 4 hours at 24, 48, 72, and 96 hours for a total of 5 doses. | Drug | Placebo |
Primary outcome
Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30
Time frame: SFISD through Day 30
The primary efficacy analysis will apply the win ratio method and the Finkelstein-Schoenfeld method to the primary endpoints. The win ratio method allocates all Auxora and placebo pairs to the components that comprise the primary endpoint in a hierarchical fashion. Categories (a) and (c) represent Auxora wins based on all-cause mortality and days ventilator-free and KRT-free. Similarly, categories (b) and (d) represent placebo wins. Category (e) represents ties. (a) Death on placebo, but alive on Auxora at day 30 (b) Death on Auxora, but alive on placebo at day 30 (e) Death on placebo and death on Auxora at day 30 If alive on placebo and alive on Auxora at day 30: (c) Greater number of days alive, ventilator-free and KRT-free on Auxora (d) Greater number of days alive, ventilator-free and KRT-free on Placebo (e) Equal number of days alive, ventilator-free and KRT-free We will calculate the overall win ratio by adding (a) + (c) and dividing it by the sum of (b) + (d).
11 secondary outcomes
Major adverse kidney event (MAKE) 90-1: ≥25% decline in estimated glomerular filtration rate (eGFR) from baseline, incident KRT, and all-cause mortality at 90 days
Time frame: At Day 90
MAKE 90-2: ≥35% decline in eGFR from baseline, incident KRT, and all-cause mortality at 90 days
Time frame: At Day 90
Proportion of patients alive at Day 30
Time frame: At Day 30
Proportion of patients alive at Day 90
Time frame: Day 90
Days alive and ventilator-free from start of first infusion of study drug (SFISD) through Day 30
Time frame: SFISD through Day 30
Days alive and KRT-free from SFISD through Day 30
Time frame: SFISD through Day 30
Proportion of patients recovered from AHRF through Day 30 as categorized by an 8-point ordinal scale
Time frame: SFISD through Day 30
Proportion of patients receiving KRT at Day 30
Time frame: At Day 30
Proportion of patients receiving KRT at Day 90
Time frame: At Day 90
Number of patients with treatment-related adverse events (TEAE)
Time frame: SFISD through Day 90
Number of patients with grade 3 TEAEs
Time frame: SFISD through Day 90
Results and safety
The study was stopped early (reason given: The study was stopped due to imbalance in randomization stratification of severe patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudarshan Hebbar, MD, Chief Medical Officer study director
CalciMedica, Inc.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Auxora in people with Acute Kidney Injury, run by CalciMedica, Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped due to imbalance in randomization stratification of severe patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive, ventilator-free and kidney replacement therapy (KRT)-free from SFISD through Day 30 (time frame: SFISD through Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.