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Calcinosis Reduction by Pyrophosphate in SSC

Primary Purpose

Systemic Sclerosis, Scleroderma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pyrophosphate
Placebo
Sponsored by
Szeged University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Systemic Sclerosis focused on measuring calcinosis, pyrophosphate

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • to meet ACR/ EULAR classification criteria

Exclusion Criteria:

  • severe upper minfestation of SSC
  • hypo- or hyperthyreoidism
  • QT prolongation on ECG

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Pyrophosphate

    Placebo

    Arm Description

    Disodium pyrophosphate

    Glucose

    Outcomes

    Primary Outcome Measures

    Change in the size of calcinosis nodues.
    Volumetric assessment with low energy CT

    Secondary Outcome Measures

    Change of the severity of sympthoms caused by calcinosis
    Visual analogue scale (0-100)
    Change of the activity of calcinosis
    Visual analogue scale (0-100)
    Change of the size of calcinosis by ultrasound
    Volumetric assessment by ultrasound

    Full Information

    First Posted
    July 14, 2021
    Last Updated
    May 23, 2023
    Sponsor
    Szeged University
    Collaborators
    Research Centre for Natural Sciences, University of Debrecen Dept. of Rheumatology
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04966416
    Brief Title
    Calcinosis Reduction by Pyrophosphate in SSC
    Official Title
    The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    June 30, 2025 (Anticipated)
    Study Completion Date
    June 30, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Szeged University
    Collaborators
    Research Centre for Natural Sciences, University of Debrecen Dept. of Rheumatology

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Calcinosis, i.e. crystal-like nodules are troublesome complication of systemic sclerosis, an autoimmune disease. Pyrophosphate inhibits its formation is laborytory. We would like to test if orally administered pyrophosphate prevents calcinosis formation.
    Detailed Description
    Calcinosis, the formation of hydroxyapatite subcutaneous nodules, often complicates systemic sclerosis. There is no standard treatment for it. Based upon our preclinical experienc, we would like to test it orally administered pyrophosphate inhibits calciosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Sclerosis, Scleroderma
    Keywords
    calcinosis, pyrophosphate

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Pyrophosphate
    Arm Type
    Experimental
    Arm Description
    Disodium pyrophosphate
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Glucose
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Pyrophosphate
    Intervention Description
    50 mg/kg bwt once daily in gelatine capsules.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Placebo
    Intervention Description
    Glucose in gelatine capsules.
    Primary Outcome Measure Information:
    Title
    Change in the size of calcinosis nodues.
    Description
    Volumetric assessment with low energy CT
    Time Frame
    52 weeks+ 16 weeks
    Secondary Outcome Measure Information:
    Title
    Change of the severity of sympthoms caused by calcinosis
    Description
    Visual analogue scale (0-100)
    Time Frame
    52 weeks+ 16 weeks
    Title
    Change of the activity of calcinosis
    Description
    Visual analogue scale (0-100)
    Time Frame
    52 weeks+ 16 weeks
    Title
    Change of the size of calcinosis by ultrasound
    Description
    Volumetric assessment by ultrasound
    Time Frame
    52 weeks+ 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: to meet ACR/ EULAR classification criteria Exclusion Criteria: severe upper minfestation of SSC hypo- or hyperthyreoidism QT prolongation on ECG
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    László Kovács, MD, PhD
    Phone
    +36309081611
    Email
    kovacs.laszlo@med.u-szeged.hu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Márta Bocskai, MD
    Phone
    +3662341520
    Email
    bocskai.marta@med.u-szeged.hu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    László Kovács, MD, Ph.D.
    Organizational Affiliation
    Szeged University
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    András Váradi, PhD, DSc
    Organizational Affiliation
    Department of Enzymology, Research Centre for Natural Sciences
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34152415
    Citation
    Hsu VM, Kozak E, Li Q, Bocskai M, Schlesinger N, Rosenthal A, McClure ST, Kovacs L, Balint L, Szamosi S, Szucs G, Carns M, Aren K, Goldberg I, Varadi A, Varga J. Inorganic pyrophosphate is reduced in patients with systemic sclerosis. Rheumatology (Oxford). 2022 Mar 2;61(3):1158-1165. doi: 10.1093/rheumatology/keab508.
    Results Reference
    background
    PubMed Identifier
    28701330
    Citation
    Dedinszki D, Szeri F, Kozak E, Pomozi V, Tokesi N, Mezei TR, Merczel K, Letavernier E, Tang E, Le Saux O, Aranyi T, van de Wetering K, Varadi A. Oral administration of pyrophosphate inhibits connective tissue calcification. EMBO Mol Med. 2017 Nov;9(11):1463-1470. doi: 10.15252/emmm.201707532.
    Results Reference
    background

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    Calcinosis Reduction by Pyrophosphate in SSC

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