Calcinosis Reduction by Pyrophosphate in SSC

University of Szeged (SZTE)

Status: Not yet enrolling

Conditions: Scleroderma; Systemic Sclerosis

Treatments: Dietary Supplement: Pyrophosphate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04966416

CALC-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• to meet ACR/ EULAR classification criteria

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups, including a placebo group

Pyrophosphate

Experimental group

Description:

Disodium pyrophosphate

Treatment:

Dietary Supplement: Pyrophosphate

Placebo

Placebo Comparator group

Description:

Glucose

Treatment:

Dietary Supplement: Placebo