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

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03228576
• Other study ID #: TREVISE
• Status: Terminated
• Start date: April 14, 2017
• Est. completion date: December 18, 2018

Study information

• Verified date: August 2019
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunosuppression
• Kidney Transplant

Intervention

Combination Product:
• Extended release Tacrolimus-Everolimus association
Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens
France	Angers University Hospital	Angers
France	Caen University Hospital	Caen
France	Clermont Ferrand University Hospital	Clermont-Ferrand
France	Centre Hospitalier Universitaire de Poitiers	Poitiers
France	Rennes University Hospital	Rennes
France	Rouen University Hospital	Rouen
France	Strasbourg University Hospital	Strasbourg
France	Tours University Hospital	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Poitiers University Hospital	Chiesi Farmaceutici S.p.A.

Country where clinical trial is conducted

France, 

Outcome

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