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

Terminated

• Conditions: Immunosuppression; Kidney Transplant
• Interventions: Combination Product: Extended release Tacrolimus-Everolimus association

• Registration Number: NCT03228576
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-14
• Study First Submitted: 2017-06-23
• Study First Submitted QC: 2017-07-20
• Study First Posted: 2017-07-25
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TREVISE	Extended release Tacrolimus-Everolimus association	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Treatment	1 year	Describe treatments and switch modalities : tolerability with adverse events, conversion value between Prograf® and Envarsus®
Renal function	1 year	Describe the evolution of renal function during follow up : creatinine value during the study
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.
Patients description	1 year	Describe the profil of included patients
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)
clinical evolution	1 year	Describe the patients clinical evolution after a one year follow up : adverse events, renal function (creatinine)...

Trial Locations

Locations (9)

Caen University Hospital; 🇫🇷 Caen, France

Clermont Ferrand University Hospital; 🇫🇷 Clermont-Ferrand, France

Centre Hospitalier Universitaire de Poitiers; 🇫🇷 Poitiers, France

Amiens University Hospital; 🇫🇷 Amiens, France

Angers University Hospital; 🇫🇷 Angers, France

Rennes University Hospital; 🇫🇷 Rennes, France

Rouen University Hospital; 🇫🇷 Rouen, France

Strasbourg University Hospital; 🇫🇷 Strasbourg, France

Tours University Hospital; 🇫🇷 Tours, France