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Completed

NCT Number: NCT05747274

SRDK0921_ Analytical Performance Study

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

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Key information

Conditions

Kidney Transplant Rejection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes hospital

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. AUC (Area Under the Receiver-Operating Characteristic [ROC] Curve)

    Time frame: 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 outcomes

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

    Time frame: at 1 year after kidney transplant

    To determine additional indicators of analytical performance of the IVD. PPV: positive predictive value NPV: negative predictive value

  2. Quantification of the gene expression signature

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

BioMAdvanced Diagnostics

Industry

Collaborators

  • Nantes University Hospital

Registry information

Official study title

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

Acronym: SRDK0921_APS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 28, 2023
Registry last updated
Nov 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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