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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 210 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-02
• Primary completion: 2023-07-05
• Completion: 2023-07-05
• First posted: 2020-10-09
• Last updated: 2024-09-19

Locations

1 site across 1 country: France