A Pilot Clinical Trial of Paricalcitol for Chronic Pancreatitis

What is the Purpose of this Study?

The purpose of this study is to examine the feasibility and acceptability of a drug called paricalcitol in adults with chronic pancreatitis (CP). The study aims to discover factors that are associated with improved symptoms when receiving paricalcitol. Findings will provide information needed to conduct larger (future) studies that evaluate the benefit of paricalcitol treatment to a portion of the CP populations likely to respond to therapy. Participants will be randomly assigned to receive either paricalcitol or placebo (inactive substance) and will complete questionnaires, in addition to other study procedures. Researchers hope that paricalcitol will have positive effects in patients with CP in reducing chronic pain associated with the disease, as well as overall quality of life and improved outcomes. The use of paricalcitol in this study is investigational.

Eligibility

* 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.

Inclusion Criteria:

* 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 a CPDPC site radiologist)
* No involvement in any interventional trials currently or within 6 months of enrollment

Exclusion Criteria:

* 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

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

A Pilot Clinical Trial of Paricalcitol for Chronic Pancreatitis

Study Details

Disease Type/Condition

Chronic Pancreatitis

Principal Investigator

Pandol, Stephen

Age Group

Adult

Phase

N/A

IRB Number

STUDY00001982

ClinicalTrials.gov ID

NCT05664880

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org