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

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

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 Overview

• Status: Terminated
• Conditions: Immunosuppression; Kidney Transplant
• Intervention / Treatment: Combination product: Extended release Tacrolimus-Everolimus association

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Amiens University Hospital
  • Angers, France, 49100
    • Angers University Hospital
  • Caen, France, 14033
    • Caen University Hospital
  • Clermont-Ferrand, France, 63000
    • Clermont Ferrand University Hospital
  • Poitiers, France, 86000
    • Centre Hospitalier Universitaire de Poitiers
  • Rennes, France, 35000
    • Rennes University Hospital
  • Rouen, France, 76000
    • Rouen University Hospital
  • Strasbourg, France, 67000
    • Strasbourg University Hospital
  • Tours, France, 37000
    • Tours University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients over 18 years old with kidney transplantation for at least one year.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TREVISE	Combination product: Extended release Tacrolimus-Everolimus association; Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus

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

Collaborators and Investigators

• Sponsor: Poitiers University Hospital
• Collaborators: Chiesi Farmaceutici S.p.A.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 14, 2017
• Primary Completion (ACTUAL): December 18, 2018
• Study Completion (ACTUAL): December 18, 2018

Study Registration Dates

• First Submitted: June 23, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (ACTUAL): July 25, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 23, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Everolimus; Tacrolimus; kidney; Transplant; Envarsus
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus; Everolimus
• Other Study ID Numbers: TREVISE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No