Immunosuppression, Kidney Transplant
Conditions
Keywords
Tacrolimus, Envarsus, Everolimus, kidney, Transplant
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.
Interventions
COMBINATION_PRODUCTExtended release Tacrolimus-Everolimus association
Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus
Sponsors
Chiesi Farmaceutici S.p.A.
Poitiers University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tolerance of the Certican®-Envarsus® association | During 1 year, between each visit (J0, M3, M6, M9, M12) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| clinical evolution | 1 year | Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)... |
| Treatment | 1 year | Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus® |
| Patients description | 1 year | Describe the profil of included patients |
| Graft Rejections and survival rates | 1 year | 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. |
| Medication compliance | 1 year | 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) |
| Renal function | 1 year | Describe the evolution of renal function during follow up : creatinine value during the study |
Countries
France
Outcome results
None listed