SRDK0921_ Analytical Performance Study (SRDK0921_APS)

BioMAdvanced Diagnostics

Status: Completed

Conditions: Kidney Transplant Rejection

Treatments: Device: SRDK0921

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05747274

SRDK0921_APS

Details and patient eligibility

About

Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)

Full description

It is a retrospective, observational, non-randomised study using clinical data and samples from DIVAT biocollection.

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.

Enrollment: 439 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects that underwent kidney transplant between January 2008 and January 2016 in the following sites: University hospital center of Nantes, AP-HP Paris-Necker, and HCL Lyon.
• 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 underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
• Subjects that have stopped immunosuppressive treatments.

Trial design

439 participants in 1 patient group

The Divat COHORT

Description:

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.

Treatment:

Device: SRDK0921