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NCT02719249 Clinical Trial

Fabry Disease Screening in ESRD Patients in West of France

ESRD Clinical Trial

— SNOUFY  

Official title:
Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02719249
Other study ID # 35RC14-9733
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 2016
Est. completion date June 30, 2018

Study information
Verified date February 2018
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.

Description:

Detection of Fabry disease is done by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date June 30, 2018
Est. primary completion date June 30, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Men less than 70 years old

- ESRD treated by dialysis or kidney graft in one of the 4 following regions : Bretagne, Centre, Pays de la Loire and Poitou-Charentes

- For unknown nephropathy OR vascular nephropathy and/or diabetic nephropathy unproved by biopsy

- Agreeing freely to participate in the study

Exclusion Criteria:

- Men less than 18 years old

- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Dried blood spot test

Locations
Country Name City State
France CHU de Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary To detect Fabry disease by dried blood spot test, in dialyzed and transplanted men, who reached ESRD for vascular or unknown disease and were not previously screened 1 year
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