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

Kidney Transplant Clinical Trial

— KTD Innov-2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04581278
• Other study ID #: RC20_0284
• Status: Recruiting
• Start date: June 2, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: June 2021
• Source: Nantes University Hospital
• Contact: Magali GIRAL, MD
• Phone: 33 2 40 08 74 43
• Email: magali.giral[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

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.

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (3)

Lead Sponsor	Collaborator
Nantes University Hospital	Hôpital Necker-Enfants Malades, Saint-Louis Hospital, Paris, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Validation of the diagnostic and/or prognostic capabilities of the SDI	The primary secondary endpoints will be to evaluate the sensitivity and specificity, as well as the negative and positive predictive values of the SDI obtained in the KTD innov-1 study, from an incident cohort of 300 new kidney transplant patients meeting the same inclusion criteria as the first KTD innov-1 study	12 months
Secondary	Providing a final report of the SDI via web interfaces	The second secondary objective is to validate the integration of the algorithms in the SDI presentation software package	12 months