A Phase 2 interventional study of Auxora and Placebo in Acute Kidney Injury, sponsored by CalciMedica, Inc.. Terminated at 33 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by CalciMedica, Inc. · Phase 2, Interventional, and Treatment
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.
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.
1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.
This study's enrollment of 122 is above the median of 100 across 817 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →CalciMedica, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Auxora
Drug: Placebo
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.
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.
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).
Time frame: SFISD through Day 30
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
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
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
Days alive and not hospitalized through Day 30
Time frame: SFISD through Day 30
Proportion of patients re-hospitalized through Day 30
Time frame: SFISD through Day 30
Proportion of patients re-hospitalized through Day 90
Time frame: SFISD through Day 90
This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Zegocractin
CalciMedica, Inc.