Calcinosis Reduction by Pyrophosphate in SSC

NCT ID: NCT04966416

Last Updated: 2023-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Systemic Sclerosis Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Pyrophosphate

Disodium pyrophosphate

Group Type EXPERIMENTAL

Pyrophosphate

Intervention Type DIETARY_SUPPLEMENT

50 mg/kg bwt once daily in gelatine capsules.

Placebo

Glucose

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Glucose in gelatine capsules.

Interventions

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Pyrophosphate

50 mg/kg bwt once daily in gelatine capsules.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Glucose in gelatine capsules.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* to meet ACR/ EULAR classification criteria

Exclusion Criteria

* severe upper minfestation of SSC
* hypo- or hyperthyreoidism
* QT prolongation on ECG
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Centre for Natural Sciences

OTHER

Sponsor Role collaborator

University of Debrecen Dept. of Rheumatology

UNKNOWN

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role lead

Responsible Party

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László Kovács MD, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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László Kovács, MD, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Szeged University

András Váradi, PhD, DSc

Role: STUDY_DIRECTOR

Department of Enzymology, Research Centre for Natural Sciences

Central Contacts

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László Kovács, MD, PhD

Role: CONTACT

+36309081611

Márta Bocskai, MD

Role: CONTACT

+3662341520

References

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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.

Reference Type BACKGROUND
PMID: 34152415 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28701330 (View on PubMed)

Other Identifiers

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CALC-001

Identifier Type: -

Identifier Source: org_study_id

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