SRDK0921_ Analytical Performance Study (SRDK0921_APS)

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

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Device: SRDK0921

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.

• Study Type: Observational
• Enrollment (Actual): 439

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • Nantes Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Samples and data from patients included in the DIVAT biocollection are the leftover specimens already used in the Proof-Of-Concept study. All those specimens meet the inclusion/exclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

The Divat COHORT; 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; 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.

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: BioMAdvanced Diagnostics
• Collaborators: Nantes University Hospital
• Investigators: Study Director: Nicolas Bouler, BioMAdvanced Diagnostics

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Actual): February 28, 2023

Study Record Updates

• Last Update Posted (Actual): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 7, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Gene expression; In Vitro Diagnostic; Subclinical rejection score, kidney allograft
• Other Study ID Numbers: SRDK0921_APS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No