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No recruitment
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| Name | Class |
|---|---|
| Chiesi Farmaceutici S.p.A. | INDUSTRY |
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The tacrolimus-Everolimus association is used as an immunospressive treatment after a kidney transplant. It combined immunosupressive properties of both products and reduce the nephrotoxicity of tacrolimus by lowering the dosage.
The commercialisation of a new extended release Tacrolimus pharmaceutical form and the lack of information justify a modality of use and tolerence evaluation of this new association, commonly used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TREVISE |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended release Tacrolimus-Everolimus association | Combination Product | Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tolerance of the Certican®-Envarsus® association | Assess clinical and biological tolerance of the Certican®-Envarsus® association on kidney transplanted patient, one year after transplant : study of adverse events with biological results (biochimy, hematology). Study of incidence of Treatment-Emergent Adverse Events. | During 1 year, between each visit (J0, M3, M6, M9, M12) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients description | Describe the profil of included patients | 1 year |
| clinical evolution | Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)... |
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Inclusion Criteria:
Exclusion Criteria:
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Patients over 18 years old with kidney transplantation for at least one year.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amiens University Hospital | Amiens | 80000 | France | |||
| Angers University Hospital |
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| 1 year |
| Treatment | Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus® | 1 year |
| Renal function | Describe the evolution of renal function during follow up : creatinine value during the study | 1 year |
| Graft Rejections and survival rates | Assess acute graft rejections (confirmed by a biopsy with the Banff classification and creatinine value) and transplants survival rates a year after the switch : all renal biopsies will be reported, with the reason for the biopsy. | 1 year |
| Medication compliance | Assess medication compliance during the switch and by the end of the study, to evaluated by doctor by asking the patient and with pharmacological concentrations (used in nephrology) | 1 year |
| Angers |
| 49100 |
| France |
| Caen University Hospital | Caen | 14033 | France |
| Clermont Ferrand University Hospital | Clermont-Ferrand | 63000 | France |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | 86000 | France |
| Rennes University Hospital | Rennes | 35000 | France |
| Rouen University Hospital | Rouen | 76000 | France |
| Strasbourg University Hospital | Strasbourg | 67000 | France |
| Tours University Hospital | Tours | 37000 | France |