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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03146793

Enrollment

600

Registered

2017-05-10

Start date

2017-05-01

Completion date

2018-02-28

Last updated

2017-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Calciphylaxis, Renal Insufficiency, Chronic

Keywords

Calciphylaxis/complications, Kidney Failure, Chronic/complications, Renal Dialysis, Thiosulfates/therapeutic use, Time Factors

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.

Interventions

DRUGSodium Thiosulfate

25g intravenously 3 times per week

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mortality	6 months

Secondary

Measure	Time frame
time factor on mortality	6 months

Countries

France

Contacts

Primary ContactAlbert TRINH-DUC, MD

albert.trinh-duc@wanadoo.fr0033675743871

Backup ContactIsabelle MOUSNIER, MD

dr_eaza@yahoo.fr0033660190002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026