DEFYT: Screening for Fabry Disease in Renal Transplantation

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03886714
• Collaborator: (none)
• Enrollment: 676
• Location: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 18.8

Study Details

Study Description

Brief Summary

Single centre, prospective pilot study examining the relevance to screen for Fabry disease in a cohort of patients who have undergone renal transplantation for nephropathy of indeterminate cause, vascular nephropathy, diabetic nephropathy or secondary focal segmental hyalinosis with no established cause.

Condition or Disease	Intervention/Treatment	Phase
Fabry Disease; Nephropathy	Diagnostic Test: Screening for Fabry disease; Diagnostic Test: Screen for α-galactosidase mutation

Detailed Description

Exploration whether Fabry disease cases can be identified among patients who are followed at the Montpellier University Hospital after renal transplantation, with indeterminate cause of renal failure or diabetic nephropathy (due to its high frequency) or secondary focal segmental hyalinosis (FSH).

At the population level, the identification of cases at the Montpellier centre could then justify to expand this screening to other French centres. The goal is to contribute to adapt current guidelines of renal failure assessment, by systematically including Fabry among the diagnostic tests. Whether all patients with renal failure are concerned, or only those with indeterminate cause, is an important question this study will address.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 676 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Screening for Fabry Disease in Renal Transplantation
• Actual Study Start Date: Mar 25, 2019
• Anticipated Primary Completion Date: Mar 25, 2021
• Anticipated Study Completion Date: Mar 25, 2022

Outcome Measures

Primary Outcome Measures

1. Number of Patients with Positive screen result [Inclusion visit]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Nephropathy of indeterminate cause, or secondary FSH or diabetic nephropathy

• Patients with kidney transplanted

• Patients still followed at the Montpellier University Hospital

• Obtaining written informed consent

• Age > 18 years old, no upper age limit

Exclusion Criteria:

• N/A

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uh Montpellier	Montpellier		France	34295

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT03886714
• Other Study ID Numbers: RECHMPL18_0015; UF 7561
• First Posted: Mar 22, 2019
• Last Update Posted: Jan 7, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Fabry disease; Renal transplantation; Diabetic nephropathy; Focal Segmental Hyalinosis (FSH); Undetermined nephropathy
• Additional relevant MeSH terms: Fabry Disease; Kidney Diseases

Study Results

No Results Posted as of Jan 7, 2020