SRDK0921_ Analytical Performance Study

NCT05747274 | Completed

• 1 other identifier: SRDK0921_APS
• Study Type: observational
• Target: 439
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Transplant Rejection

Keywords

Gene expression; In Vitro Diagnostic; Subclinical rejection score, kidney allograft

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Analytical sensitivity, specificity, Positive Predictive Value, Negative Predictive Value, Cut-off-value

  at 1 year after kidney transplant

• Quantification of the gene expression signature

  at 1 year after kidney transplant

Study Arms (1)

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

Interventions

SRDK0921 DEVICE

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.

The Divat COHORT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Subjects that underwent a graft biopsy for medical indication at one-year post- kidney transplantation.
• Subjects that have stopped immunosuppressive treatments.

Sponsors & Collaborators

• BioMAdvanced Diagnostics: lead
• Nantes University Hospital: collaborator

Study Sites (1)

Nantes hospital

Nantes, 44000, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood sample

Study Officials

• Nicolas Bouler

  BioMAdvanced Diagnostics

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 28, 2023
• Study Start: September 21, 2023
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Locations

FR (1)