Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-01 @ 9:58 AM
Study NCT ID:
NCT03146793
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Early Administration of Sodium Thiosulfate Should Help to Reduce the Mortality of Dialysis Patients With Calciphylaxis, From a National Cohort
Sponsor:
Centre Hospitalier St Esprit
Organization:
Study Overview
Official Title:
National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: