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

Poitiers University Hospital16 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Kidney Transplant Immunosuppression

Interventions

Extended release Tacrolimus-Everolimus associationCOMBINATION_PRODUCT

Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Amiens University Hospital

Amiens, France

Angers University Hospital

Angers, France

Caen University Hospital

Caen, France

Clermont Ferrand University Hospital

Clermont-Ferrand, France

Outcomes

Primary Outcomes

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.

Time frame: During 1 year, between each visit (J0, M3, M6, M9, M12)

Secondary Outcomes

Patients description

Describe the profil of included patients

Time frame: 1 year

clinical evolution

Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)...

Time frame: 1 year

Treatment

Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus®

Time frame: 1 year

Renal function

Describe the evolution of renal function during follow up : creatinine value during the study

Time frame: 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.

Time frame: 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)

Data from ClinicalTrials.gov

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