ESRDSNOUFYNCT02719249
Fabry Disease Screening in ESRD Patients in West of France
An observational study of ESRD, run by Rennes University Hospital at 1 site in France.
Trial summary
Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men only
- Conditions the study is for
- ESRD
- What is being tested?
- Dried blood spot test
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2016to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: End-stage renal disease patients
Who may be able to join
- 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
Who cannot join
- Men less than 18 years old
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- ESRD
- Being tested
- Dried blood spot test
- Keywords
- ESRD, Fabry disease
- Medical subject headings
- Kidney Failure, Chronic, Fabry Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dried blood spot testOther
| Study group | Role | What they receive |
|---|---|---|
| Men with ESRD on dialysis or transplant | Not described Receives: Other: Dried blood spot test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719249
- Sponsor's protocol ID
- 35RC14-9733
- Acronym
- SNOUFY
- Status last verified
- Feb 2018
- First submitted
- 21 Mar 2016
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fabry Disease Prevalence in End-stage Renal Disease (ESRD) Patients on Dialysis or Transplant in West of France
- ClinicalTrials.gov ID
- NCT02719249
- Acronym / sponsor ID
- SNOUFY / 35RC14-9733
- Conditions
- ESRD
- Keywords
- ESRD, Fabry disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Screening of Fabry disease in end-stage renal disease (ESRD) patients on dialysis or transplant in west of France.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Men with ESRD on dialysis or transplant | – | Other: Dried blood spot test |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- End-stage renal disease patients
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Men less than 18 years old
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dried blood spot test | Other | Men with ESRD on dialysis or transplant |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ESRD, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2018.