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

NCT04581278 | Completed

• 1 other identifier: RC20_0284
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant

Keywords

Kidney Transplant; Integrated Diagnostic System

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Validation of the diagnostic and/or prognostic capabilities of the SDI

  12 months

• Providing a final report of the SDI via web interfaces

  12 months

Interventions

KTD Innov-2 DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nantes University Hospital: lead
• Hôpital Necker-Enfants Malades: collaborator
• Saint-Louis Hospital, Paris, France: collaborator

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

The blood, urine and biopsy samples required for the construction of the SDI will be completed upon inclusion in the KTD Innov-2 protocol (D0 of the graft, blood, urine) then at 3 months (monitoring biopsy of the renal graft, blood and urine) and 12 months (kidney transplant monitoring biopsy, blood and urine) in the 300 incident patients from the 3 university hospitals of the study (Nantes, Necker and Paris Saint-Louis). A blood and urine sample will accompany each graft biopsy which will be indicated in the first year of transplant.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: October 9, 2020
• Study Start: June 2, 2021
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (1)