Calcinosis Reduction by Pyrophosphate in SSC

May 23, 2023 updated by: László Kovács MD, PhD, Szeged University

The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • to meet ACR/ EULAR classification criteria

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pyrophosphate
Disodium pyrophosphate
Dietary supplement: Pyrophosphate
50 mg/kg bwt once daily in gelatine capsules.
Placebo Comparator: Placebo
Glucose
Dietary supplement: Placebo
Glucose in gelatine capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the size of calcinosis nodues.
Time Frame: 52 weeks+ 16 weeks
Volumetric assessment with low energy CT
52 weeks+ 16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of the severity of sympthoms caused by calcinosis
Time Frame: 52 weeks+ 16 weeks
Visual analogue scale (0-100)
52 weeks+ 16 weeks
Change of the activity of calcinosis
Time Frame: 52 weeks+ 16 weeks
Visual analogue scale (0-100)
52 weeks+ 16 weeks
Change of the size of calcinosis by ultrasound
Time Frame: 52 weeks+ 16 weeks
Volumetric assessment by ultrasound
52 weeks+ 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Szeged University

Collaborators

Research Centre for Natural Sciences
University of Debrecen Dept. of Rheumatology

Investigators

  • Principal Investigator: László Kovács, MD, Ph.D., Szeged University
  • Study Director: András Váradi, PhD, DSc, Department of Enzymology, Research Centre for Natural Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

July 14, 2021

First Submitted That Met QC Criteria

July 16, 2021

First Posted (Actual)

July 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 25, 2023

Last Update Submitted That Met QC Criteria

May 23, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CALC-001

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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