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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-14

Study Completion Date

2018-12-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Everolimus in Combination With Tacrolimus in Liver Transplant Recipients

NCT01551212

Liver Transplantation

COMPLETED PHASE4

Pharmacokinetic Study on the Combination of Everolimus-Tacrolimus

NCT00325325

Kidney Diseases

UNKNOWN PHASE2

Extended Release Tacrolimus vs. Twice-Daily Tacrolimus

NCT03289650

End Stage Renal Disease Rejection of Renal Transplant

COMPLETED PHASE3

Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function

NCT02334488

Chronic Kidney Disease

COMPLETED PHASE3

Non-inferiority Study of Safety and Efficacy of Everolimus With Low Dose Tacrolimus to Mycophenolate Mofetil With Standard Dose Tacrolimus in Kidney Transplant Recipients

NCT01025817

Kidney Transplant

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Kidney Transplant Immunosuppression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TREVISE

Extended release Tacrolimus-Everolimus association

Intervention Type COMBINATION_PRODUCT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Extended release Tacrolimus-Everolimus association

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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No