Actively Recruiting

Early Phase 1
Age: 18Years - 75Years
All Genders
NCT05664880

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Led by Cedars-Sinai Medical Center · Updated on 2025-11-14

24

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

Sponsors

C

Cedars-Sinai Medical Center

Lead Sponsor

N

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed and dated informed consent form
  • Willingness to comply with all study procedures and availability for the study duration
  • Male or female, aged 18-75 years at enrollment
  • Diagnosis of chronic pancreatitis not due to gallstones, medications, trauma, or autoimmune pancreatitis
  • Ability to take oral medication and adhere to 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)
  • Females of reproductive potential must use highly effective contraception for at least 1 month prior to screening and during the study plus 1 week after treatment
  • Males of reproductive potential must use condoms or other effective contraception methods
  • No prior pancreatic surgery
  • Pancreatic necrosis less than 50% as verified by radiologist
  • No involvement in interventional trials currently or within 6 months prior to enrollment
Not Eligible

You will not qualify if you...

  • Pregnancy or lactation
  • History of autoimmune or traumatic pancreatitis, or acute necrotizing pancreatitis with suspected disconnected duct syndrome
  • Primary pancreatic tumors including ductal adenocarcinoma, cystic neoplasm larger than 1 cm or involving main duct, neuroendocrine tumors, or other rare tumors
  • Pancreatic metastasis from other cancers
  • History of solid organ transplant or HIV/AIDS
  • Abnormal calcium, phosphate, or parathyroid hormone lab values
  • Known isolated pancreatic exocrine insufficiency without other eligible inclusion criteria
  • Medical, psychiatric illness or substance abuse that would impair participation or treatment tolerance
  • Abnormal creatinine (GFR less than 30) or renal failure
  • Known pregnancy; females of childbearing potential must have negative pregnancy test within 2 days prior to research procedures
  • Currently incarcerated
  • Inability to tolerate MRI

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

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Research Team

A

Arax Shanlian

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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