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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Kidney Transplant

Treatments: Diagnostic Test: KTD Innov-2

Study type: Observational

Funder types: Other

Identifiers

NCT04581278

RC20_0284

Details and patient eligibility

About

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.

Enrollment: 210 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)