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 (KTD Innov-2)

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.

Study Overview

• Status: Recruiting
• Conditions: Kidney Transplant
• Intervention / Treatment: Diagnostic test: KTD Innov-2

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Magali GIRAL, MD; Phone Number: 33 2 40 08 74 43; Email: magali.giral@chu-nantes.fr

Study Locations

• France
  • Loire-Atlantique
    • Nantes, Loire-Atlantique, France, 44093
      • Recruiting
      • Nantes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Inclusion of patients receiving a kidney transplant from a living donor Inclusion of patients receiving a kidney transplant from a deceased donor

300 patients from 3 French centers routinely performing surveillance kidney graft biopsies at 3 months and 1 year of grafting. The 3 centres participating in the KTD Innov-2 study are the Nantes, Necker and Saint-Louis University Hospitals (Paris).

Description

Inclusion Criteria :

• Male and female patients, age ≥ 18 years at time of transplantation.
• Patients with a minimum weight of 40 kg in order to allow blood samples to be taken safely in accordance with the table published in the Order of 12 April 2018 setting the list of research mentioned in 3° of Article L. 1121-1 of the Public Health Code.
• Patients receiving a kidney transplant from a living or brain-dead donor.
• Patients expressing their non-opposition and ready to comply with the study procedures.

Exclusion Criteria :

• Patients who have received a previous transplant with an organ other than the kidney
• Patients unable or unwilling to perform study procedures or who do not speak French
• Vulnerable patients (minors, adults, pregnant women, under guardianship)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of the diagnostic and/or prognostic capabilities of the SDI	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	12 months
Providing a final report of the SDI via web interfaces	The second secondary objective is to validate the integration of the algorithms in the SDI presentation software package	12 months

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Saint-Louis Hospital, Paris, France; Hôpital Necker-Enfants Malades

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 2, 2021
• Primary Completion (ANTICIPATED): October 1, 2022
• Study Completion (ANTICIPATED): October 1, 2022

Study Registration Dates

• First Submitted: September 3, 2020
• First Submitted That Met QC Criteria: October 2, 2020
• First Posted (ACTUAL): October 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 3, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Kidney Transplant; Integrated Diagnostic System
• Other Study ID Numbers: RC20_0284

Plan for Individual participant data (IPD)

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

IPD Plan Description

eCRF

The collection of data on each person suitable for research is carried out through a coded database. This coded database will be extracted from the existing DIVAT database in each participating centre, and the variables specific to the KTD Innov study (patient identification number (centre number/patient number) for the study, inclusion/non-inclusion criteria, date of collection of the non-opposition, additional analyses, ...) will be added on specific tabs.

Drug and device information, study documents

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