The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort

NCT ID: NCT03146793

Last Updated: 2017-05-10

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

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-05-01

Study Completion Date

2018-02-28

Brief Summary

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The national drug safety agency authorizes nominatively the use of sodium thiosulfate in dialysis patients with calciphylaxis. To date, it is the largest global cohort (more 600 patients from 2012 to 2016). We wanted to study retrospectively the fate of these patients at 6 months including mortality. Early use improves effectiveness.

Detailed Description

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Conditions

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Calciphylaxis Renal Insufficiency, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Sodium Thiosulfate

25g intravenously 3 times per week

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All dialysis patients with calciphylaxis in France who have obtained a temporary use authorization for sodium thiosulfate by National Agency for the Safety of Medicines

Exclusion Criteria

* N/A
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier St Esprit

OTHER

Sponsor Role lead

Responsible Party

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Albert TRINH-DUC

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Albert TRINH-DUC, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier St EPSRIT AGEN FRANCE

Locations

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Centre Hospitalier St ESPRIT

Agen, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Albert TRINH-DUC, MD

Role: CONTACT

0033675743871

Isabelle MOUSNIER, MD

Role: CONTACT

0033660190002

Facility Contacts

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Albert TRINH-DUC, MD

Role: primary

0033675743871

Isabelle MOUSNIER, MD

Role: backup

0033660190002

References

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Weenig RH, Sewell LD, Davis MD, McCarthy JT, Pittelkow MR. Calciphylaxis: natural history, risk factor analysis, and outcome. J Am Acad Dermatol. 2007 Apr;56(4):569-79. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1.

Reference Type BACKGROUND
PMID: 17141359 (View on PubMed)

Perceau G. [Uraemic and non-uraemic calcific arteriopathy: The need for rapid diagnosis and therapy]. Ann Dermatol Venereol. 2015 Aug-Sep;142(8-9):506-12. doi: 10.1016/j.annder.2015.06.009. Epub 2015 Aug 5. French.

Reference Type BACKGROUND
PMID: 26253008 (View on PubMed)

Nigwekar SU, Brunelli SM, Meade D, Wang W, Hymes J, Lacson E Jr. Sodium thiosulfate therapy for calcific uremic arteriolopathy. Clin J Am Soc Nephrol. 2013 Jul;8(7):1162-70. doi: 10.2215/CJN.09880912. Epub 2013 Mar 21.

Reference Type BACKGROUND
PMID: 23520041 (View on PubMed)

Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Kruger T, Floege J, Ketteler M. Calcific uraemic arteriolopathy (calciphylaxis): data from a large nationwide registry. Nephrol Dial Transplant. 2017 Jan 1;32(1):126-132. doi: 10.1093/ndt/gfv438.

Reference Type BACKGROUND
PMID: 26908770 (View on PubMed)

Sood AR, Wazny LD, Raymond CB, Leung K, Komenda P, Reslerova M, Verrelli M, Rigatto C, Sood MM. Sodium thiosulfate-based treatment in calcific uremic arteriolopathy: a consecutive case series. Clin Nephrol. 2011 Jan;75(1):8-15.

Reference Type BACKGROUND
PMID: 21176746 (View on PubMed)

Other Identifiers

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Centre Hospitalier St Esprit

Identifier Type: -

Identifier Source: org_study_id

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