NCT03228576

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 25, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2018

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

1.7 years

First QC Date

June 23, 2017

Last Update Submit

August 23, 2019

Conditions

Kidney TransplantImmunosuppression

Keywords

TacrolimusEnvarsusEverolimuskidneyTransplant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Patients description

    1 year

  • clinical evolution

    1 year

  • Treatment

    1 year

  • Renal function

    1 year

  • Graft Rejections and survival rates

    1 year

  • +1 more secondary outcomes

Study Arms (1)

TREVISE

Combination Product: Extended release Tacrolimus-Everolimus association

Interventions

Extended release Tacrolimus-Everolimus associationCOMBINATION_PRODUCT

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

TREVISE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Amiens University Hospital

Amiens, 80000, France

Location

Angers University Hospital

Angers, 49100, France

Location

Caen University Hospital

Caen, 14033, France

Location

Clermont Ferrand University Hospital

Clermont-Ferrand, 63000, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, 86000, France

Location

Rennes University Hospital

Rennes, 35000, France

Location

Rouen University Hospital

Rouen, 76000, France

Location

Strasbourg University Hospital

Strasbourg, 67000, France

Location

Tours University Hospital

Tours, 37000, France

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2017

First Posted

July 25, 2017

Study Start

April 14, 2017

Primary Completion

December 18, 2018

Study Completion

December 18, 2018

Last Updated

August 28, 2019

Record last verified: 2019-08

Locations

FR(9)