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

• Conditions: Calciphylaxis; Renal Insufficiency, Chronic

• Registration Number: NCT03146793
• Lead Sponsor: Centre Hospitalier St Esprit

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-05
• Study Start: 2017-05-01
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2017-05-08
• Last Update Submitted: 2017-05-08
• Study First Posted: 2017-05-10
• Last Update Posted: 2017-05-10
• Primary Completion: 2017-12-31
• Study Completion: 2018-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	6 months

Secondary Outcome Measures

Name	Time	Method
time factor on mortality	6 months

Trial Locations

Locations (1)

Centre Hospitalier St ESPRIT; 🇫🇷 Agen, France