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

CompletedOBSERVATIONAL
Enrollment

210

Participants

Timeline

Start Date

June 2, 2021

Primary Completion Date

July 5, 2023

Study Completion Date

July 5, 2023

Conditions
Kidney Transplant
Interventions
DIAGNOSTIC_TEST

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.~300 kidney transplant patients will be included in the KTD Innov-2 study with data collection, blood, urine and graft biopsies for biomarker analysis and conversion to SDI (decisional algorithms) and interactive multi-dimensional presentation on a web interface for use of the tool by transplant physicians and their patients."

Trial Locations (1)

44093

Nantes University Hospital, Nantes

All Listed Sponsors
collaborator

Hôpital Necker-Enfants Malades

OTHER

collaborator

Saint-Louis Hospital, Paris, France

OTHER

lead

Nantes University Hospital

OTHER