Testing paricalcitol for chronic pancreatitis

A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

This study is testing whether the drug paricalcitol can improve the quality of life for adults with chronic pancreatitis compared to a placebo.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cedars-Sinai Medical Center (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT05664880 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the feasibility and acceptability of paricalcitol in adults suffering from chronic pancreatitis. It will assess the drug's effects on health-related quality of life, imaging results, and biomarker analysis. Participants will undergo MRI and DEXA scans to monitor their condition and bone mineral density, comparing those receiving paricalcitol to a placebo group. The study will also collect routine lab results to identify any adverse events or safety concerns throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a diagnosis of chronic pancreatitis not caused by gallstones, medications, trauma, or autoimmune conditions.

Not a fit: Patients with chronic pancreatitis due to gallstones or other specific etiologies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option that alleviates symptoms of chronic pancreatitis.

How similar studies have performed: While this approach is novel, preclinical evidence suggests that vitamin D analogues may have beneficial effects on pancreatitis.

Eligibility criteria

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 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
* Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria)
* 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

Where this trial is running

Los Angeles, California

• Cedars-Sinai Medical Center — Los Angeles, California, United States (RECRUITING)

Study contacts

• Principal investigator: Stephen Pandol, MD — Cedars-Sinai Medical Center
• Study coordinator: Arax Shanlian

Conditions: Chronic Pancreatitis, Paricalcitol