Calcinosis Reduction by Pyrophosphate in SSC

Not Applicable

Not yet recruiting

• Conditions: Systemic Sclerosis; Scleroderma

• Registration Number: NCT04966416
• Lead Sponsor: Szeged University

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.

Study Timeline

• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-16
• Study First Posted: 2021-07-19
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-23
• Last Update Posted: 2023-05-25
• Study Start: 2023-08-01
• Primary Completion: 2025-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• to meet ACR/ EULAR classification criteria

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in the size of calcinosis nodues.	52 weeks+ 16 weeks	Volumetric assessment with low energy CT

Secondary Outcome Measures

Name	Time	Method
Change of the size of calcinosis by ultrasound	52 weeks+ 16 weeks	Volumetric assessment by ultrasound
Change of the severity of sympthoms caused by calcinosis	52 weeks+ 16 weeks	Visual analogue scale (0-100)
Change of the activity of calcinosis	52 weeks+ 16 weeks	Visual analogue scale (0-100)