Trial · NCT04681066
A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
NCT04681066, Phase 2, Completed, CalciMedica, Inc.; results first posted 2025-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS. Trials, record NCT04681066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04681066
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Auxora in Patients With Acute Pancreatitis and Accompanying SIRS
- NCT number
- NCT04681066
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 216 participants, actual
- Lead sponsor
- CalciMedica, Inc.
- Conditions
- Acute Pancreatitis, Systemic Inflammatory Response Syndrome
- Interventions
- CM-4620 Injectable Emulsion or CM-4620-IE, Placebo
- First posted
- 2020-12-23
- Last updated
- 2026-08-24
- Results first posted
- 2025-10-16
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | from start of first infusion of study drug (SFISD) through day 30 | Time to Solid Food Tolerance (TSFT): Number of hours from date/time of SFISD to date/time patient receives a solid meal that is tolerated, defined as eating \>/=50% of a low fat \>/= 500-calorie solid meal w/o increase in abdominal pain or vomiting within 2 hours of mealtime. If patient was discharged w/o tolerating solid food, the daily record of the modified ANMS Gastrointestinal Cardinal Symptom Index Daily Diary (mGCSI-DD) at or after hospital discharge was used to calculate TSFT. For these patients, TSFT date/time was considered to be 8am on the first of 3 consecutive days where the following criteria were met in mGCSI-DD: no vomiting, no or mild nausea, no or mild inability to finish a normal sized meal, no or mild abdominal pain. gMCP-Mod: Generalized Multiple Comparisons and Modeling--3 steps: 1) Hazard ratio (dose vs placebo) using stratified Cox regression w/ stratification by sex and hematocrit (high/low). 2) Multiple contrast test. 3) Find best-fit dose-response model. |
| Secondary | Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship | from enrollment and through day 30 | Analysis of patients without respiratory failure at the time of randomization (defined as a P/F ratio ≤300 measured by an arterial blood gas or imputed from pulse oximetry) who later developed severe respiratory failure during the course of the study. |
| Secondary | Incidence, Severity, and Duration of Organ Failure | from enrollment and through day 30 | The incidence, severity and duration of organ failure was defined by the development of severe respiratory failure or severe renal failure or severe cardiac failure. The proportion of patients who developed each type of organ failure, or multi-organ failure (more than 1 organ failure), was analyzed. |
| Secondary | Solid Food Tolerance | from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge (up to 30 days after SFISD) | Number (and percentage) of patients who tolerated solid food at 48hrs, 72hrs, and 96hrs from start of first infusion of study drug, as well as at time of first discharge from hospital |
| Secondary | Time to Medically Indicated Discharge | from start of first infusion of study drug through time of hospital discharge or through Day 30, whichever occurs first | The time (in hours) to medically indicated discharge, defined as the number of days from the SFISD to the first date of meeting the criteria below: * the patient tolerated solid food, as defined by the main analytical approach; and * abdominal pain was controlled or resolved, which was defined by a reduction in pain, as assessed by the PNRS scale, of ≥50% from the peak level in the first 24 hours and no use of opioids; and * no clinical evidence of an infection requiring continued hospitalization. Kaplan-Meier (K-M) estimates of median time to medically indicated discharge are shown. |
| Secondary | Length of Stay in the Hospital | from admission date into the hospital until discharge date from the hospital | Number of days in the hospital during the first 30 Days of the Study from the SFISD (start of first infusion of study drug) while still alive, for any reason. Includes ICU stay and readmissions. The number of days in the hospital before the patient's death was used in the analysis.(Note: there was only 1 patient death in this study, in the 1.0 mg/kg Auxora group) |
| Secondary | Re-hospitalization for Acute Pancreatitis by Day 30 | time from initial date of hospital discharge through date of re-hospitalization through day 30 | The proportion of patients who were re-hospitalized for either acute pancreatitis, or the development of pancreatic necrosis/necrotizing pancreatitis through the Day 30 visit. |
| Secondary | Change in Severity of Acute Pancreatitis by CTSI Score From Screening to Day 30 | From informed consent through day 30 | Independent reviewers performed a blinded central review of Contrast Enhanced Computed Tomography (CECT) imaging data, or MRI imaging data, obtained at the Screening and Day 30 visits to assess the Computed Tomography Severity Index (CTSI). Review was performed by two independent radiologists (primary review) using a consensus methodology. The CTSI scoring uses a combination of Balthazar score grading of pancreatitis (A-E) and grading the extent of pancreatic necrosis (none, ≤30%, \>30-50%, or \>50%) to designate AP as mild, moderate, or severe. Proportion of patients with moderate or severe AP by CTSI score at baseline who became mild AP at Day 30, and the proportion of patients with mild AP by CTSI at baseline who had moderate or severe AP at Day 30 were analyzed. |
| Secondary | Development of Pancreatic Necrosis ≥30% and >50% | from enrollment CECT through Day 30 CECT | Development of pancreatic necrosis ≥30% and \>50% in patients who had no pancreatic necrosis at screening (Note: There were no patients with pancreatic necrosis at screening in any of the treatment groups.) |
| Secondary | The Persistence of SIRS ≥48 Hours After the SFISD | from SFISD through day 30 | The proportion of patients who developed persistence of SIRS ≥48 Hours after the SFISD analyzed through Day 30. If the patient was discharged before 48 Hours after the SFISD, the last available post-treatment data was used to define the SIRS status at 48 hours after the SFISD based on the LOCF method. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | from start of first infusion of study drug (SFISD) through day 30 | Analysis for all treated patients and the high hematocrit subgroup are presented. | Hours | MEDIAN |
| SECONDARY | Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship | from enrollment and through day 30 | Only the subset of patients without respiratory failure at the time of randomization (defined as a P/F ratio ≤300 measured by an arterial blood gas or imputed from pulse oximetry) were included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Incidence, Severity, and Duration of Organ Failure | from enrollment and through day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Solid Food Tolerance | from SFISD to 48 hours, 72 hours and 96 hours and at time of hospital discharge (up to 30 days after SFISD) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Medically Indicated Discharge | from start of first infusion of study drug through time of hospital discharge or through Day 30, whichever occurs first | hours | MEDIAN | |
| SECONDARY | Length of Stay in the Hospital | from admission date into the hospital until discharge date from the hospital | days | MEAN | |
| SECONDARY | Re-hospitalization for Acute Pancreatitis by Day 30 | time from initial date of hospital discharge through date of re-hospitalization through day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Severity of Acute Pancreatitis by CTSI Score From Screening to Day 30 | From informed consent through day 30 | Patients were divided into two subgroups for this analysis: those with Moderate or Severe AP by CTSI score at baseline, and those with Mild AP by CTSI score at baseline. Analysis only includes subjects with non-missing Screening and Day 30 Visit (or post-treatment unscheduled visit) CTCE reading results. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Development of Pancreatic Necrosis ≥30% and >50% | from enrollment CECT through Day 30 CECT | Only subjects with non-missing Screening and Day 30 Visit (or post-treatment unscheduled visit) CTCE reading results were analyzed | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | The Persistence of SIRS ≥48 Hours After the SFISD | from SFISD through day 30 | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 2.0 mg/kg (1.25 mL/kg) | All Patients | 67.0 | 95% Confidence Interval 39.0 to 91.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 1.0 mg/kg (0.625 mL/kg) | All Patients | 64.0 | 95% Confidence Interval 43.0 to 93.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 0.5 mg/kg (0.3125 mL/kg) | All Patients | 78.0 | 95% Confidence Interval 39.0 to 118.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Placebo (1.25, 0.625, or 0.3125 mL/kg) | All Patients | 66.0 | 95% Confidence Interval 44.0 to 116.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 2.0 mg/kg (1.25 mL/kg) | High Hematocrit subgroup | 67.0 | 95% Confidence Interval 26.0 to 95.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 1.0 mg/kg (0.625 mL/kg) | High Hematocrit subgroup | 64.0 | 95% Confidence Interval 20.0 to 101.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 0.5 mg/kg (0.3125 mL/kg) | High Hematocrit subgroup | 78.0 | 95% Confidence Interval 37.0 to 167.0 | Hours |
| Median Time to Solid Food Tolerance, With gMCP Modeling Analysis for Dose-response Relationship | Placebo (1.25, 0.625, or 0.3125 mL/kg) | High Hematocrit subgroup | 113.5 | 95% Confidence Interval 40.0 to 187.0 | Hours |
| Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 2.0 mg/kg (1.25 mL/kg) | 0 | Participants | ||
| Percentage of Patients With New Onset Severe Respiratory Failure, With gMCP Modeling Analysis for Dose-response Relationship | Auxora 1.0 mg/kg (0.625 mL/kg) | 0 | Participants |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Auxora 2.0 mg/kg (1.25 mL/kg) | 54 | |
| Overall Study | STARTED | Auxora 1.0 mg/kg (0.625 mL/kg) | 56 | |
| Overall Study | STARTED | Auxora 0.5 mg/kg (0.3125 mL/kg) | 53 | |
| Overall Study | STARTED | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 53 | |
| Overall Study | COMPLETED | Auxora 2.0 mg/kg (1.25 mL/kg) | 49 | |
| Overall Study | COMPLETED | Auxora 1.0 mg/kg (0.625 mL/kg) | 53 | |
| Overall Study | COMPLETED | Auxora 0.5 mg/kg (0.3125 mL/kg) | 51 | |
| Overall Study | COMPLETED | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 49 | |
| Overall Study | NOT COMPLETED | Auxora 2.0 mg/kg (1.25 mL/kg) | 5 | |
| Overall Study | NOT COMPLETED | Auxora 1.0 mg/kg (0.625 mL/kg) | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events748
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Auxora 2.0 mg/kg (1.25 mL/kg) | 3 | 53 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Auxora 1.0 mg/kg (0.625 mL/kg) | 3 | 56 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Auxora 0.5 mg/kg (0.3125 mL/kg) | 2 | 52 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 2 | 53 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Auxora 2.0 mg/kg (1.25 mL/kg) | 0 | 53 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Auxora 1.0 mg/kg (0.625 mL/kg) | 0 | 56 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Auxora 0.5 mg/kg (0.3125 mL/kg) | 3 | 52 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 0 | 53 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Auxora 2.0 mg/kg (1.25 mL/kg) | 0 | 53 | 0 |
| other | Heparin-induced thrombocytopenia | Blood and lymphatic system disorders | Auxora 1.0 mg/kg (0.625 mL/kg) | 0 | 56 | 0 |
1 to 10 of 748Source ClinicalTrials.gov
See all 748 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Auxora 2.0 mg/kg (1.25 mL/kg) | 0 | 53 |
| Total, all-cause mortality | Auxora 1.0 mg/kg (0.625 mL/kg) | 1 | 56 |
| Total, all-cause mortality | Auxora 0.5 mg/kg (0.3125 mL/kg) | 0 | 52 |
| Total, all-cause mortality | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 0 | 53 |
| Total, other adverse events | Auxora 2.0 mg/kg (1.25 mL/kg) | 22 | 53 |
| Total, other adverse events | Auxora 1.0 mg/kg (0.625 mL/kg) | 32 | 56 |
| Total, other adverse events | Auxora 0.5 mg/kg (0.3125 mL/kg) | 26 | 52 |
| Total, other adverse events | Placebo (1.25, 0.625, or 0.3125 mL/kg) | 23 | 53 |
| Total, serious adverse events | Auxora 2.0 mg/kg (1.25 mL/kg) | 8 | 53 |
| Total, serious adverse events | Auxora 1.0 mg/kg (0.625 mL/kg) | 12 | 56 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41938843 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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