Kidney Transplant Rejection
Conditions
Keywords
Gene expression, In Vitro Diagnostic, Subclinical rejection score, kidney allograft
Brief summary
Analytical Performance Study of the SRDK0921 IVD medical device (Kit and Software)
Detailed 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.
Interventions
DEVICESRDK0921
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.
Sponsors
Nantes University Hospital
BioMAdvanced Diagnostics
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve) | at 1 year after kidney transplant | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value | at 1 year after kidney transplant | To determine additional indicators of analytical performance of the IVD. PPV: positive predictive value NPV: negative predictive value |
| Quantification of the gene expression signature | at 1 year after kidney transplant | To assess the correlation level between the prior Proof-of-Concept study and this study based on the 2 genes expression signature. |
Countries
France
Outcome results
None listed