A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

NCT05664880 | Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: STUDY000019821R01DK132631-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pancreatitis

Keywords

Paricalcitol

Outcome Measures

Primary Outcomes (1)

• Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis

  The proposed trial will examine the feasibility of testing the effect of the vitamin D analogue called paricalcitol (also known as Zemplar), on health-related quality of life, imaging, and biomarkers in patients with chronic pancreatitis (CP). Health-related quality of life measurements will be collected via questionnaires to assess overall health, quality of life, and pain. An Acceptability Form will be provided during the last visit to gauge the general acceptability of the intervention. Feasibility will be met if ≥75% of enrolled patients complete the 12-month study. There will be a 21-month recruitment period and a one-year treatment period.

  End of study (12 Months)

Secondary Outcomes (1)

• Compare the mean change in health related quality of life from baseline across the times points 6 and 12 months between the treatment group and placebo

  End of study (12 Months)

Study Arms (2)

Paricalcitol

EXPERIMENTAL

Participants receive Paricalcitol 2mcg capsule once daily for 12 months.

Drug: Paricalcitol

Placebo

PLACEBO COMPARATOR

Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.

Drug: Placebo

Interventions

Paricalcitol DRUG

2 MCG Oral Capsule

Paricalcitol

Placebo DRUG

Matching capsule to 2 MCG Paricalcitol Oral Capsule

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• 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

You may not qualify if:

• Pregnancy or lactation
• 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
• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen Pandol, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arax Shanlian

CONTACT

3109671110; arax.shanlian@cshs.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Basic and Translational Pancreas Research Medicine

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 27, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)