SRDK0921_ Analytical Performance Study

BioMAdvanced Diagnostics439 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

439

Conditions

Kidney Transplant Rejection

Interventions

SRDK0921DEVICE

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nantes hospital

Nantes, France

Outcomes

Primary Outcomes

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.

Time frame: at 1 year after kidney transplant

Secondary Outcomes

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

Time frame: 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.

Time frame: at 1 year after kidney transplant

Data from ClinicalTrials.gov

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