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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05747274
Other study ID # SRDK0921_APS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 21, 2023
Est. completion date September 29, 2023

Study information

Verified date November 2023
Source BioMAdvanced Diagnostics
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 439
Est. completion date September 29, 2023
Est. primary completion date September 29, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
France Nantes hospital Nantes

Sponsors (2)

Lead Sponsor Collaborator
BioMAdvanced Diagnostics Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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