Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
439 participants
OBSERVATIONAL
2023-09-21
2023-09-29
Brief Summary
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Detailed Description
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The aim of this study is to validate the analytical performance of the SRDK0921 In Vitro Diagnostic Medical Device (IVD).
The SRDK0921 system (kit and software) is intended:
* to calculate a score of subclinical rejection in kidney transplant patients
* as an aid in diagnosis of subclinical rejection's absence in kidney transplant recipients in conjunction with other clinical information.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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The Divat COHORT
The DIVAT cohort (Computerized and Validated Data in Transplantation) developed by the Immunology and Nephrology Department of the University Hospital of Nantes (France) , is a biocollection database linked to clinical data and plasma, serum, blood cells and urines of all kidney recipients from Nantes, Paris-Necker, and Lyon centres. The clinical and biological parameters are collected at 3 months, 6 months, 1 year and then every year.
All available specimens in the DIVAT cohort that:
* meet inclusion and exclusion criteria of this study AND
* are usable in terms of quality, integrity, and quantity. will be analysed for this study in order to maximise the power and generalisability of the results.
SRDK0921
SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746.
Interventions
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SRDK0921
SRDK0921 is an IVD composed of IVD kit for qPCR (SRDK0921KIT) and a cloud-based software (SRDK0921SOFT). It is a class C, rule 3k, IVD according to Regulation (EU) 2017/746.
Eligibility Criteria
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Inclusion Criteria
* Subjects transplanted from living or deceased donors.
* Patients with an available paired frozen mRNA and biopsy collected at one-year post- transplantation and archived in the DIVAT bio-collection.
* Subjects with good kidney function at one-year post-transplantation (creatininemia below 160 µmol. L-1)
* Subjects under standard immunosuppressive treatments.
Exclusion Criteria
* Subjects that have stopped immunosuppressive treatments.
18 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
BioMAdvanced Diagnostics
INDUSTRY
Responsible Party
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Principal Investigators
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Nicolas Bouler
Role: STUDY_DIRECTOR
BioMAdvanced Diagnostics
Locations
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Nantes hospital
Nantes, , France
Countries
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Other Identifiers
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SRDK0921_APS
Identifier Type: -
Identifier Source: org_study_id
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