Clinical trial NCT03228576: Prospective Cohort of Kidney Transplanted Patients Receiving an Extended Releasing Tacrolimus-Everolimus Association
Official title: Observationnal Multicenter Study on a Prospective Cohort of Kidney Transplanted Patients Receiving a Year After Transplant an Extended Releasing Tacrolimus-Everolimus Association
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Kidney Transplant
Immunosuppression
Keywords: Tacrolimus
Envarsus
Everolimus
kidney
Transplant
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2017-07-25
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old with kidney transplantation for at least one year.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Tolerance of the Certican®-Envarsus® association
timeFrame: During 1 year, between each visit (J0, M3, M6, M9, M12)
Secondary outcomes:
measure: Patients description
timeFrame: 1 year
measure: clinical evolution
timeFrame: 1 year
measure: Treatment
timeFrame: 1 year
measure: Renal function
timeFrame: 1 year
measure: Graft Rejections and survival rates
timeFrame: 1 year
measure: Medication compliance
timeFrame: 1 year
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens University Hospital
city: Angers
country: France
facility: Angers University Hospital
city: Caen
country: France
facility: Caen University Hospital
city: Clermont-Ferrand
country: France
facility: Clermont Ferrand University Hospital
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers
city: Rennes
country: France
facility: Rennes University Hospital
city: Rouen
country: France
facility: Rouen University Hospital
city: Strasbourg
country: France
facility: Strasbourg University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
References: