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

Renal Insufficiency, Chronic Clinical Trial

Official title:

National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03146793
• Other study ID #: Centre Hospitalier St Esprit
• Status: Recruiting
• Phase: N/A
• First received: May 8, 2017
• Last updated: May 8, 2017
• Start date: May 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: May 2017
• Source: Centre Hospitalier St Esprit
• Contact: Albert TRINH-DUC, MD
• Phone: 0033675743871
• Email: albert.trinh-duc[@]wanadoo.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: February 28, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Calciphylaxis
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• Sodium Thiosulfate
25g intravenously 3 times per week

Locations

Country	Name	City	State
France	Centre Hospitalier St ESPRIT	Agen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier St Esprit

Country where clinical trial is conducted

France, 

References & Publications (5)

Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Krüger 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Dec 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		6 months
Secondary	time factor on mortality		6 months