UMEM Research Studies

A Randomized, Double-Blind, Placebo Controlled Dose Ranging Study of Auxora in Patients with Acute Pancreatitis and Accompanying Systemic Inflammatory Response Syndrome (CARPO) - Completed

Sponsor: CalciMedica, Inc. | Status: Completed

Start Date: 03/02/2023 | End Date: -

Principal Investigator(s)
Gentry Wilkerson

Secondary Investigator(s)

Description:

Study Treatments 

Approximately 216 patients with acute pancreatitis (AP) and accompanying systemic inflammatory response syndrome (SIRS) will be randomized at into four groups on a 1:1:1:1 basis, resulting in 54 patients randomized into each group at approximately 30 sites.Patients randomized to receive Auxorawill receive one of three dose levels, 2.0 mg/kg (1.25 mL/kg), 1.0 mg/kg (0.625 mL/kg), and 0.5 mg/kg (0.3125 mL/kg), or placebo every 24 hours (±1 hour) for three consecutive days for a total of three infusions. Auxora will be administered intravenously as a continuous infusion over 4 hours via a bag and tubing compatible with lipid emulsions and using a 1.2-micron filter. 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. 

 

Primary Endpoint 

  • Time to solid food tolerance 

Secondary Endpoints 

  • Solid food tolerance at 48 hours, 72 hours, and 96 hours after the Start of First Infusion of Study Drug (SFISD) and at discharge 

  • Time to medically indicated discharge 

  • Length of stay in the hospital 

  • Length of stay in the ICU for patients admitted to the ICU 

  • Re-hospitalization for AP by Day 30 

  • Change in severity of AP by CTSI score from screening to Day 30 

  • Development of pancreatic necrosis ≥30% and >50% 

  • The persistence of SIRS ≥48 hours after the SFISD 

  • Incidence, severity, and duration of organ failure 

  • Mortality by Day 30 

  • Change in pain score and opioid use 

Keywords: CARPO, pancreatitis