SRDK0921_ Analytical Performance Study

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

Detailed Description
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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.

Official Title
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Retrospective Study to Validate the Analytical Performance of an In Vitro Diagnostic (IVD) Medical Device in Patients With Kidney Transplant.

Conditions
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Kidney Transplant Rejection

Intervention / Treatment
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* Device: SRDK0921


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The Divat COHORT<br>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. | Device: SRDK0921<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve) | To determine the analytical performance meaning the discriminating ability of the IVD (kit and software), between patients displaying a sub-clinical rejection and patients without subclinical rejection, confirmed with the gold standard method (graft biopsy). An AUC ≥ 0.75 was considered as clinically acceptable. | at 1 year after kidney transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value | To determine additional indicators of analytical performance of the IVD. PPV: positive predictive value NPV: negative predictive value | at 1 year after kidney transplant | 
| Quantification of the gene expression signature | To assess the correlation level between the prior Proof-of-Concept study and this study based on the 2 genes expression signature. | at 1 year after kidney transplant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gene expression, In Vitro Diagnostic, Subclinical rejection score, kidney allograft