Validation Study of the Feasibility of an Integrated Diagnostic System of Anatomo-pathological Lesions - Including Rejections - Appearing in Renal Grafts in the First Year of Transplant for Applicability in Routine Clinical Practice : KTD Innov-2 Study

• Conditions: Kidney Transplant

• Registration Number: NCT04581278
• Lead Sponsor: Nantes University Hospital

Brief Summary

The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-10-02
• Study First Posted: 2020-10-09
• Status Verified: 2021-06
• Study Start: 2021-06-02
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-08
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of the sample circuit from clinical unit to processing platforms	12 months	Path of the biological samples (blood, urine, biopsies) to the sample processing platforms for the editing of the raw results of the blood and urine and biopsy biomarkers
Validation of a final report	12 months	Edition of a final numerical report of the algorithms accessible on a web support with an intelligible interpretation by clinicians and patients.
Collection of biological samples necessary for the construction of the SDI	12 months	Validation of the circuit for the collection of the blood, urine and biopsy samples
Validation of raw results transmission	12 months	The transmission of the raw results in the format necessary for the calculation of the diagnostic and/or prognostic algorithms

Secondary Outcome Measures

Name	Time	Method
Validation of the diagnostic and/or prognostic capabilities of the SDI	12 months	The primary secondary endpoints will be to evaluate the sensitivity and specificity, as well as the negative and positive predictive values of the SDI obtained in the KTD innov-1 study, from an incident cohort of 300 new kidney transplant patients meeting the same inclusion criteria as the first KTD innov-1 study
Providing a final report of the SDI via web interfaces	12 months	The second secondary objective is to validate the integration of the algorithms in the SDI presentation software package

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, Loire-Atlantique, France