Prospective Cohort of Kidney Transplanted Patients Receiving an Extended Releasing Tacrolimus-Everolimus Association

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association

Conditions
-----------------
Kidney Transplant, Immunosuppression

Intervention / Treatment
-----------------
* Combination Product: Extended release Tacrolimus-Everolimus association


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years old Patients informed and giving his agreement to the use of every collected data Patients with kidney transplantation for at least one year and being treated with the immunosppressive assiociation of Tacrolimus (Prograf ®)-Everolimus Patients whose investigators decides to switch from Prograf ® to an Envarsus ®-Everolimus association Exclusion Criteria: Other transplantation Drug or alcohol abuse Patients unable to understand the purpose or modalities of this study, unable to give his agreement or unable to stick to the protocol Patients on an interventionnal protocol when included

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TREVISE<br> | Combination Product: Extended release Tacrolimus-Everolimus association<br>* Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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)... | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tacrolimus, Envarsus, Everolimus, kidney, Transplant