Calcinosis Reduction by Pyrophosphate in SSC

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04966416
• Other study ID #: CALC-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: Szeged University
• Contact: László Kovács, MD, PhD
• Phone: +36309081611
• Email: kovacs.laszlo[@]med.u-szeged.hu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• to meet ACR/ EULAR classification criteria

Exclusion Criteria:

• severe upper minfestation of SSC

• hypo- or hyperthyreoidism

• QT prolongation on ECG

Related Conditions & MeSH terms

• Calcinosis
• Scleroderma
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Dietary Supplement:
• Pyrophosphate
50 mg/kg bwt once daily in gelatine capsules.
• Placebo
Glucose in gelatine capsules.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Szeged University	Research Centre for Natural Sciences, University of Debrecen Dept. of Rheumatology

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the size of calcinosis nodues.	Volumetric assessment with low energy CT	52 weeks+ 16 weeks
Secondary	Change of the severity of sympthoms caused by calcinosis	Visual analogue scale (0-100)	52 weeks+ 16 weeks
Secondary	Change of the activity of calcinosis	Visual analogue scale (0-100)	52 weeks+ 16 weeks
Secondary	Change of the size of calcinosis by ultrasound	Volumetric assessment by ultrasound	52 weeks+ 16 weeks