Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Actively Recruiting
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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