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International, multicentre, randomized 1:1 controlled trial to prove the clinical and medico economic benefits of the medical device Predigraft, by showing that the use of Predigraft could improve patient's follow-up.
The study aims to demonstrate improvement of the prevalence of biopsies leading to therapeutic change in the Predigraft group compared to the Standard of care group in kidney transplanted patients.
It is hypothesized that using Predigraft as a monitoring tool will help the physician detect earlier and more often abnormalities with the patient allograft. This should lead to an increased number of biopsies leading to therapeutic change. These biopsies should be performed earlier than without the iBox monitoring tool. This would improve long-term allograft function, kidney allograft and patient survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predigraft | Experimental | Subjects will have a clinical follow-up based on site standard of care and benefit from follow-up using Predigraft in addition of the standard of care: the investigator will receive an alert every time there is a subject's instability, instability based on the following criteria: allograft survival assessed by iBox decreased by at least 5% in the last 12 months. |
|
| Standard of Care | No Intervention | Subjects will have a clinical follow-up based on site standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Predigraft | Device | The Subject randomized to the Predigraft will benefit from Predigraft, a remote monitoring software that issues an alert to the investigator when the allograft survival prediction calculated by the iBox algorithm is decreasing. This follow-up is on top of the site's standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| number of biopsies leading to therapeutic change | number of biopsies leading to therapeutic change by the end of the follow-up (18 months). | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Lapse of time between the detection of kidney allograft instability and the biospy | Lapse of time between the detection of kidney allograft instability (i.e. Predigraft alert on patient's instability) and performing the biopsy. | 18 months |
| Renal function |
| Measure | Description | Time Frame |
|---|---|---|
| Patient related outcome measures | Patient related outcome measures: results of SF-36 (36-Item Short Form Health Survey) (quality of life: score 0 to 100 / 0 being the worst perception of health status) questionnaire at the end of the follow-up compared to baseline. | 18 months |
| Medico-economic evaluation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre LOUPY, Pr | Necker Hospital, Paris, France | Study Chair |
| Carmen LEFAUCHEUR, Pr | St Louis Hospital, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medizinische Universität Innsbruck | Innsbruck | 6020 | Austria | |||
| Hôpital Saint-Louis |
Data will be communicated to other researchers in an aggregated manner
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randomized 1:1 , controlled, open label study
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|
|
Renal function estimated by eGFR |
| 18 months |
| Patient outcome | Patient outcome evaluated by a composite endpoint: graft loss + patient death + eGFR < 30 mL/min/1.73m2 by the end of the follow-up. | 18 months |
| iBox predicted allograft survival | iBox predicted allograft survival: 7-year kidney allograft predictions by the end of the follow-up. | 18 months |
| Number of therapeutic changes | Number of therapeutic changes by the end of the follow-up. | 18 months |
| Number of unnecessary biopsies | Number of unnecessary biopsies by the end of the follow-up. | 18 months |
Medico-economic evaluation based on days of hospitalization, treatment cost and return to dialysis at 18 months |
| 18 months |
| Paris |
| France |
| 75010 |
| France |
| Hôpital Tenon | Paris | France | 75020 | France |
| CHU Rangueil | Toulouse | France | 31400 | France |
| Hôpital Necker | Paris | 75015 | France |
| Universitätsklinikum Düsseldorf AÖR | Düsseldorf | 40225 | Germany |
| Universitätsklinikum Hamburg-Eppendorf | Hamburg | 20251 | Germany |
| Sourasky Medical Center - Ichilov Hospital | Tel Aviv | 6423906 | Israel |
| Hospital Del Mar - Parc de Salut Mar | Barcelona | 08003 | Spain |
| Fundació Puigvert | Barcelona | 08025 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| Queen Elizabeth Hospital | Birmingham | B15 2GW | United Kingdom |
| Leeds Teaching Hospital NHS Trust | Leeds | LS9 7TF | United Kingdom |
| Guy's & Saint Thomas' NHS Foundation Trust | London | SE1 9RT | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Oxford Transplant Centre | Oxford | OX3 7LE | United Kingdom |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007676 | Kidney Failure, Chronic |
| D012059 | Rejection, Psychology |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012919 | Social Behavior |
| D001519 | Behavior |
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