A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
NCT ID: NCT05664880
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
EARLY_PHASE1
24 participants
INTERVENTIONAL
2023-06-01
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Paricalcitol
Participants receive Paricalcitol 2mcg capsule once daily for 12 months.
Paricalcitol
2 MCG Oral Capsule
Placebo
Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.
Placebo
Matching capsule to 2 MCG Paricalcitol Oral Capsule
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paricalcitol
2 MCG Oral Capsule
Placebo
Matching capsule to 2 MCG Paricalcitol Oral Capsule
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Stated willingness to comply with all study procedures and availability for the duration 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 autoimmune pancreatitis.
* 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 at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 1 week after the end of Investigational Product administration
* For males of reproductive potential: use of condoms or other methods to ensure effective 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 of enrollment
* Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up
* Patients with known abnormal creatinine (GFR \< 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP.
* Known Pregnancy. All participants of childbearing potential, except if post-menopausal \[i.e. no menses for ≥2 years\] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test
* Currently incarcerated
* Inability to tolerate MRI
Exclusion Criteria
* History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome
* Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (\>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
* Pancreatic metastasis from other malignancies
* History of solid organ transplant, HIV/AIDS.
* Abnormal lab values: calcium, phosphate, or parathyroid hormone
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Cedars-Sinai Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Stephen Pandol, MD
Director, Basic and Translational Pancreas Research Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stephen Pandol, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars-Sinai Medical Center
Los Angeles, California, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Arax Shanlian
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00001982
Identifier Type: -
Identifier Source: org_study_id