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| Name | Class |
|---|---|
| Hôpital Necker-Enfants Malades | OTHER |
| Saint-Louis Hospital, Paris, France | OTHER |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria :
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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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nantes University Hospital | Nantes | Loire-Atlantique | 44093 | France |
eCRF
The collection of data on each person suitable for research is carried out through a coded database. This coded database will be extracted from the existing DIVAT database in each participating centre, and the variables specific to the KTD Innov study (patient identification number (centre number/patient number) for the study, inclusion/non-inclusion criteria, date of collection of the non-opposition, additional analyses, ...) will be added on specific tabs.
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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.
| 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 |