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Status unknownNCT03146793Updated May 10, 2017

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

An observational study in Calciphylaxis and Renal Insufficiency, Chronic, sponsored by Centre Hospitalier St Esprit. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-10.

Sponsored by Centre Hospitalier St Esprit · Observational

The sponsor has not verified this record recently (last verified May 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Calciphylaxis
  • Renal Insufficiency, Chronic

Keywords

  • Calciphylaxis/complications
  • Kidney Failure, Chronic/complications
  • Renal Dialysis
  • Thiosulfates/therapeutic use
  • Time Factors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Dialysis patients with calciphylaxis

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

Exclusion Criteria:

  • N/A
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
600 participants (estimated)
Patient registry
No

Interventions

  • DrugSodium Thiosulfate

    25g intravenously 3 times per week

05

What researchers measure

Primary outcomes

  1. Mortality

    Time frame: 6 months

Secondary outcomes

  1. time factor on mortality

    Time frame: 6 months

06

Study locations

1 of 1 sites recruiting
  • Centre Hospitalier St ESPRIT
    Agen, 47000, France
    Recruiting
07

References and documents

Publications

  • 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. doi: 10.1016/j.jaad.2006.08.065. Epub 2006 Dec 1. PubMed 17141359 ↗
  • 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. PubMed 26253008 ↗
  • 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. PubMed 23520041 ↗
  • Brandenburg VM, Kramann R, Rothe H, Kaesler N, Korbiel J, Specht P, Schmitz S, Kruger 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. PubMed 26908770 ↗
  • 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. PubMed 21176746 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03146793
Lead sponsor
Centre Hospitalier St Esprit
Responsible party
Albert TRINH-DUC (Principal investigator, Centre Hospitalier St Esprit) — Principal investigator
First posted
May 10, 2017
Start date
May 1, 2017
Primary completion
Dec 31, 2017 (estimated)
Completion
Feb 28, 2018 (estimated)
Last update
May 10, 2017

Study contacts

Albert TRINH-DUC, MD
Contact
albert.trinh-duc@wanadoo.fr
0033675743871
Isabelle MOUSNIER, MD
Contact
dr_eaza@yahoo.fr
0033660190002
Albert TRINH-DUC, MD
principal investigator · Centre Hospitalier St EPSRIT AGEN FRANCE

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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