Fabry Disease Screening in ESRD Patients in West of France (SNOUFY)

August 27, 2018 updated by: Rennes University Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rennes, France, 35033
        • CHU de RENNES

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

End-stage renal disease patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men with ESRD on dialysis or transplant
Other: Dried blood spot test

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 28, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 35RC14-9733

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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