Clinical trial NCT04581278: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Keywords: Kidney Transplant
Integrated Diagnostic System
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Hôpital Necker-Enfants Malades
name: Saint-Louis Hospital, Paris, France
First posted: 2020-10-09
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Collection of biological samples necessary for the construction of the SDI
timeFrame: 12 months
measure: Validation of the sample circuit from clinical unit to processing platforms
timeFrame: 12 months
measure: Validation of raw results transmission
timeFrame: 12 months
measure: Validation of a final report
timeFrame: 12 months
Secondary outcomes:
measure: Validation of the diagnostic and/or prognostic capabilities of the SDI
timeFrame: 12 months
measure: Providing a final report of the SDI via web interfaces
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References: