A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis (ALLIANCE)

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Drug: Paricalcitol; Drug: Placebo

Detailed Description

Examine the feasibility of a trial to test the effect of paricalcitol through health-related quality of life, imaging, and biomarker analysis in patients with chronic pancreatitis (CP). The study hopes the proposed intervention will improve symptoms based on preclinical evidence that vitamin D analogues have significant and beneficial effects on pancreatitis cancer by blocking certain signaling proteins to reduce pain.

Medical history, concomitant medications, and laboratory test results will be reviewed at all visits by one of the study physicians. In addition, at the beginning and end of the study period, patients will have an MRI to assess condition and DEXA scan to measure bone mineral density, to compare and determine if those receiving paricalcitol have a clinically significant decrease in bone mineral density compared to those receiving placebo for safety. In addition to scans, routine labs will be obtained to assess for any adverse events or safety concerns. Mechanistic specimens for research purposes will be collected at each of the following in person visits: Screening/Randomization, Month 6, Month 12.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Marissa Podell; Phone Number: 310-967-1109; Email: marissa.podell@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Marissa Podell
      • Principal Investigator: Stephen Pandol, MD
      • Contact: Marissa Podell; Phone Number: 310-967-1109; Email: marissa.podell@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Paricalcitol; Participants receive Paricalcitol 2mcg capsule once daily for 12 months.	Drug: Paricalcitol; 2 MCG Oral Capsule
Placebo Comparator: Placebo; Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.	Drug: Placebo; Matching capsule to 2 MCG Paricalcitol Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis	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.	End of study (12 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare the mean change in health related quality of life from baseline across the times points 6 and 12 months between the treatment group and placebo	The study will monitor health-related quality of life measures, imaging, and biomarkers to identify potential measures of response to treatment with the intent do develop larger efficacy focused trials.	End of study (12 Months)

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Stephen Pandol, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 16, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Paricalcitol
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Pancreatic Diseases; Chronic Disease; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: STUDY00001982; 1R01DK132631-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes