SRDK0921_ Analytical Performance Study

Kidney Transplant Rejection Clinical Trial

— SRDK0921_APS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05747274
• Other study ID #: SRDK0921_APS
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Kidney Transplant Rejection

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