Calcinosis Reduction by Pyrophosphate in SSC

• Sponsor: Szeged University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04966416
• Collaborator: Research Centre for Natural Sciences (Other), University of Debrecen Dept. of Rheumatology (Other)
• Enrollment: 60
• Arms: 2
• Anticipated Duration (Months): 35

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Sclerosis; Scleroderma	Dietary Supplement: Pyrophosphate; Dietary Supplement: Placebo	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: The Effect of Orally Administered Pyrophosphate on Calcinosis Formation in Systematic Sclerosis
• Anticipated Study Start Date: Aug 1, 2021
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyrophosphate	Dietary Supplement: Pyrophosphate; 50 mg/kg bwt once daily in gelatine capsules.
Placebo Comparator: Placebo	Dietary Supplement: Placebo; Glucose in gelatine capsules.

Outcome Measures

Primary Outcome Measures

1. Change in the size of calcinosis nodues. [52 weeks+ 16 weeks]

   Volumetric assessment with low energy CT

Secondary Outcome Measures

1. Change of the severity of sympthoms caused by calcinosis [52 weeks+ 16 weeks]

   Visual analogue scale (0-100)

2. Change of the activity of calcinosis [52 weeks+ 16 weeks]

   Visual analogue scale (0-100)

3. Change of the size of calcinosis by ultrasound [52 weeks+ 16 weeks]

   Volumetric assessment by ultrasound

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• to meet ACR/ EULAR classification criteria

Exclusion Criteria:

• severe upper minfestation of SSC

• hypo- or hyperthyreoidism

• QT prolongation on ECG

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Szeged University
• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: László Kovács MD, PhD, Professor, Szeged University
• ClinicalTrials.gov Identifier: NCT04966416
• Other Study ID Numbers: CALC-001
• First Posted: Jul 19, 2021
• Last Update Posted: Jul 19, 2021
• Last Verified: Jul 1, 2021

• 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
• Keywords provided by László Kovács MD, PhD, Professor, Szeged University: calcinosis; pyrophosphate
• Additional relevant MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Calcinosis; Sclerosis

Study Results

No Results Posted as of Jul 19, 2021