Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03146793
Recruitment Status : Unknown
Verified May 2017 by Albert TRINH-DUC, Centre Hospitalier St Esprit.
Recruitment status was:  Recruiting
First Posted : May 10, 2017
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Albert TRINH-DUC, 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.

Condition or disease Intervention/treatment
Calciphylaxis Renal Insufficiency, Chronic Drug: Sodium Thiosulfate

Layout table for study information
Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: National Follow-up of Dialysis Patients With Sodium Thiosufate-treated Calciphylaxis Under Temporary Use Authorization
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis


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


Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. time factor on mortality [ Time Frame: 6 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Dialysis patients with calciphylaxis
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03146793


Contacts
Layout table for location contacts
Contact: Albert TRINH-DUC, MD 0033675743871 albert.trinh-duc@wanadoo.fr
Contact: Isabelle MOUSNIER, MD 0033660190002 dr_eaza@yahoo.fr

Locations
Layout table for location information
France
Centre Hospitalier St ESPRIT Recruiting
Agen, France, 47000
Contact: Albert TRINH-DUC, MD    0033675743871    albert.trinh-duc@wanadoo.fr   
Contact: Isabelle MOUSNIER, MD    0033660190002    dr_eaza@yahoo.fr   
Sub-Investigator: David LARMET BURGEOT, MD         
Sponsors and Collaborators
Centre Hospitalier St Esprit
Investigators
Layout table for investigator information
Principal Investigator: Albert TRINH-DUC, MD Centre Hospitalier St EPSRIT AGEN FRANCE

Publications:
Layout table for additonal information
Responsible Party: Albert TRINH-DUC, Principal investigator, Centre Hospitalier St Esprit
ClinicalTrials.gov Identifier: NCT03146793     History of Changes
Other Study ID Numbers: Centre Hospitalier St Esprit
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Albert TRINH-DUC, Centre Hospitalier St Esprit:
Calciphylaxis/complications
Kidney Failure, Chronic/complications
Renal Dialysis
Thiosulfates/therapeutic use
Time Factors

Additional relevant MeSH terms:
Layout table for MeSH terms
Sodium thiosulfate
Renal Insufficiency
Renal Insufficiency, Chronic
Calciphylaxis
Kidney Diseases
Urologic Diseases
Calcinosis
Calcium Metabolism Disorders
Metabolic Diseases
Antidotes
Protective Agents
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Chelating Agents
Sequestering Agents