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Completed

NCT Number: 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

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.

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Key information

Conditions

Kidney Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Collection of biological samples necessary for the construction of the SDI

    Time frame: 12 months

    Validation of the circuit for the collection of the blood, urine and biopsy samples

  2. Validation of the sample circuit from clinical unit to processing platforms

    Time frame: 12 months

    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

  3. Validation of raw results transmission

    Time frame: 12 months

    The transmission of the raw results in the format necessary for the calculation of the diagnostic and/or prognostic algorithms

  4. Validation of a final report

    Time frame: 12 months

    Edition of a final numerical report of the algorithms accessible on a web support with an intelligible interpretation by clinicians and patients.

Secondary outcomes

  1. Validation of the diagnostic and/or prognostic capabilities of the SDI

    Time frame: 12 months

    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

  2. Providing a final report of the SDI via web interfaces

    Time frame: 12 months

    The second secondary objective is to validate the integration of the algorithms in the SDI presentation software package

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Hôpital Necker-Enfants Malades
  • Saint-Louis Hospital, Paris, France

Registry information

Acronym: KTD Innov-2

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 9, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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