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Anti-inflammatory agent

Auxora for Acute Pancreatitis (CARPO Trial)

Phase 2
Waitlist Available
Research Sponsored by CalciMedica, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The diagnosis of acute pancreatitis has been established by the presence of abdominal pain consistent with acute pancreatitis together with at least 1 of the following 2 criteria:
The patient is willing and able to, or has a legal authorized representative (LAR) who is willing and able to, provide informed consent to participate, and to cooperate with all aspects of the protocol.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment through day 30
Awards & highlights

CARPO Trial Summary

This trial will study the effects of Auxora, a new potential treatment for acute pancreatitis, in 216 patients. Patients will be randomly assigned to one of three dose levels of Auxora or one of three placebo volumes. Study drug infusions will occur every 24 hours for three consecutive days for a total of three infusions. Patients will remain hospitalized as per standard of care and once discharged will be asked to complete a daily meal diary and return for a Day 30 safety assessment.

Who is the study for?
This trial is for adults with acute pancreatitis and SIRS, confirmed by specific lab tests, imaging, and symptoms. Participants must not have chronic pancreatitis or a history of certain pancreatic conditions. They should be free from severe infections like HIV/hepatitis, not on dialysis or recent other trials, and willing to use birth control if applicable.Check my eligibility
What is being tested?
The study compares Auxora at different doses against a placebo in patients with acute pancreatitis accompanied by SIRS. It's double-blind (neither doctors nor patients know who gets what), involving three daily infusions over three days while hospitalized.See study design
What are the potential side effects?
While the side effects are not explicitly listed here, common risks may include allergic reactions to the drug components (e.g., egg allergies), potential infection risk due to weakened immune responses from treatment, and general discomfort from infusion.

CARPO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with acute pancreatitis.
Select...
I or my legal representative can consent to and follow the study requirements.
Select...
I am 18 years old or older.

CARPO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from sfisd to 48 hours, 72 hours and 96 hours and at time of hospital discharge
This trial's timeline: 3 weeks for screening, Varies for treatment, and from sfisd to 48 hours, 72 hours and 96 hours and at time of hospital discharge for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to solid food tolerance
Secondary outcome measures
Change in opioid use
Pain
Change in severity of acute pancreatitis by CTSI score from screening to Day 30
+9 more
Other outcome measures
Change in ANC/ALC ratio and IL-6 levels
Change in GCSI-DD score
Change in albumin
+4 more

CARPO Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: 0.5 mg/kg (0.3125 mL/kg)Active Control1 Intervention
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Group II: 2.0 mg/kg (1.25 mL/kg)Active Control1 Intervention
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Group III: 1.0 mg/kg (0.625 mL/kg)Active Control1 Intervention
administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.
Group IV: Placebo (1.25, 0.625, or 0.3125 mL/kg)Placebo Group1 Intervention
patients randomized to placebo will receive one of three following volumes (1.25 mL/kg, 0.625 mL/kg, and 0.3125 mL/kg. although three volumes - all patients randomized to placebo will be analyzed together as one arm. administered intravenously over 4 hours at a constant rate of infusion. They will be administered every 24 hours (±1 hours) for three consecutive days for a total of 3 doses.

Find a Location

Who is running the clinical trial?

CalciMedica, Inc.Lead Sponsor
7 Previous Clinical Trials
513 Total Patients Enrolled
3 Trials studying Acute Pancreatitis
70 Patients Enrolled for Acute Pancreatitis
Sudarshan Hebbar, MDStudy DirectorCalciMedica, Inc.
4 Previous Clinical Trials
312 Total Patients Enrolled
2 Trials studying Acute Pancreatitis
28 Patients Enrolled for Acute Pancreatitis

Media Library

CM-4620 Injectable Emulsion or CM-4620-IE (Anti-inflammatory agent) Clinical Trial Eligibility Overview. Trial Name: NCT04681066 — Phase 2
Acute Pancreatitis Research Study Groups: Placebo (1.25, 0.625, or 0.3125 mL/kg), 0.5 mg/kg (0.3125 mL/kg), 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg)
Acute Pancreatitis Clinical Trial 2023: CM-4620 Injectable Emulsion or CM-4620-IE Highlights & Side Effects. Trial Name: NCT04681066 — Phase 2
CM-4620 Injectable Emulsion or CM-4620-IE (Anti-inflammatory agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04681066 — Phase 2
~16 spots leftby Sep 2024
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