NCT05664880 · Cedars-Sinai Medical Center
A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
(ALLIANCE)
What this study is about
The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).
View original scientific description
The purpose of this pilot study to examine the feasibility and acceptability of paricalcitol in adults with Chronic Pancreatitis (CP).
Interventions
DRUG
Paricalcitol
2 MCG Oral Capsule
DRUG
Placebo
Matching capsule to 2 MCG Paricalcitol Oral Capsule
Primary outcome measures
Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis
Time frame: End of study (12 Months)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Los Angeles, California
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 14, 2025 · Source of record for eligibility and locations