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

Primary Purpose

Chronic Pancreatitis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Paricalcitol
Placebo
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pancreatitis focused on measuring Paricalcitol

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cedars-Sinai Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paricalcitol

Placebo

Arm Description

Participants receive Paricalcitol 2mcg capsule once daily for 12 months.

Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 7, 2022
Last Updated
August 18, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT05664880
Brief Title
A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
Acronym
ALLIANCE
Official Title
A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
January 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

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

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis
Keywords
Paricalcitol

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
Participants receive Paricalcitol 2mcg capsule once daily for 12 months.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive Paricalcitol Placebo capsule matching Paricalcitol once daily for 12 months.
Intervention Type
Drug
Intervention Name(s)
Paricalcitol
Intervention Description
2 MCG Oral Capsule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching capsule to 2 MCG Paricalcitol Oral Capsule
Primary Outcome Measure Information:
Title
Examine the feasibility of testing the effect of paricalcitol on health-related quality of life in patients with chronic pancreatitis
Description
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.
Time Frame
End of study (12 Months)
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
End of study (12 Months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert Marker
Phone
310-423-0901
Email
robert.marker@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Pandol, MD
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Marker
Phone
310-423-0901
Email
robert.marker@cshs.org
First Name & Middle Initial & Last Name & Degree
Stephen Pandol, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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A PiLot ClinicaL TrIal of ParicAlcitol for ChroNiC PancrEatitis

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