A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Last updated: April 9, 2025
Sponsor: Cedars-Sinai Medical Center
Overall Status: Active - Recruiting

Phase

1

Condition

Pancreatitis

Primary Biliary Cholangitis

Treatment

Placebo

Paricalcitol

Clinical Study ID

NCT05664880
STUDY00001982
1R01DK132631-01
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of signed and dated informed consent form

  • Stated willingness to comply with all study procedures and availability for theduration of the study

  • Male or female, aged 18-75 at time of enrollment

  • Diagnosis of Chronic Pancreatitis episode is not attributable to gallstones (i.e.suspected or definite biliary etiology), medications, trauma or autoimmunepancreatitis.

  • Ability to take oral medication and be willing to adhere to the dosing regimen

  • Normal Calcium levels- 8.5 to 10.2 mg/dL

  • Normal Phosphate levels- 2.8 to 4.5 mg/dL

  • Normal Parathyroid hormone levels- 10 to 65 pg/mL

  • For females of reproductive potential: use of highly effective contraception for atleast 1 month prior to screening and agreement to use such a method during studyparticipation and for an additional 1 week after the end of Investigational Productadministration

  • For males of reproductive potential: use of condoms or other methods to ensureeffective contraception with partner

  • No prior pancreatic surgery

  • Pancreatic necrosis, if present, is <50% (to be verified by radiologist)

  • No involvement in any interventional trials currently or within 6 months ofenrollment

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation

  • History of autoimmune or traumatic pancreatitis, or sentinel attack of acutenecrotizing pancreatitis which results in suspected disconnected duct syndrome

  • Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cysticneoplasm (>1 cms in size or main duct involvement), neuroendocrine tumors, and otheruncommon tumors.

  • Pancreatic metastasis from other malignancies

  • History of solid organ transplant, HIV/AIDS.

  • Abnormal lab values: calcium, phosphate, or parathyroid hormone

  • Known isolated pancreatic exocrine insufficiency (e.g. in the absence of anyeligible inclusion criteria)

  • Participants must not have medical or psychiatric illnesses or ongoing substanceabuse that in the investigator's opinion would compromise their ability to toleratestudy interventions or participate in longitudinal follow up

  • Patients with known abnormal creatinine (GFR < 30) or renal failure (applies topatients with chronic upper abdominal pain of suspected pancreatic origin andsuspected CP.

  • Known Pregnancy. All participants of childbearing potential, except ifpost-menopausal [i.e. no menses for ≥2 years] or had a hysterectomy, bilateral tuballigation/clip (surgical sterilization) or surgical removal of both the ovaries),must have a negative urine or serum B-HCG pregnancy test documented within 2 daysprior to any endoscopic or radiologic procedures done for research purposes. Anystandard of care tests will follow institutional policies regarding pregnancy test

  • Currently incarcerated

  • Inability to tolerate MRI

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 1
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Examine the feasibility of a trial to test the effect of paricalcitol through health-related quality of life, imaging, and biomarker analysis in patients with chronic pancreatitis (CP). The study hopes the proposed intervention will improve symptoms based on preclinical evidence that vitamin D analogues have significant and beneficial effects on pancreatitis cancer by blocking certain signaling proteins to reduce pain.

Medical history, concomitant medications, and laboratory test results will be reviewed at all visits by one of the study physicians. In addition, at the beginning and end of the study period, patients will have an MRI to assess condition and DEXA scan to measure bone mineral density, to compare and determine if those receiving paricalcitol have a clinically significant decrease in bone mineral density compared to those receiving placebo for safety. In addition to scans, routine labs will be obtained to assess for any adverse events or safety concerns. Mechanistic specimens for research purposes will be collected at each of the following in person visits: Screening/Randomization, Month 6, Month 12.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Marissa Maiman

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Marissa Podell

    Los Angeles, California 90048
    United States

    Active - Recruiting

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