Envarsus 4 mg prolonged-release tablets

DRUG8 trials

Sponsors

Universitaetsklinikum Regensburg, Centre Hospitalier Universitaire De Limoges, Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC), Universitaetsklinikum Schleswig-Holstein AöR

Conditions

Caucasian paediatric kidney transplant recipientsICD 10: Z94.4 Liver transplant statusProphylaxis of transplant rejection in adult kidney allograft recipientsProphylaxis of transplant rejection in adult liver allograft recipientsRenal transplantationkidney failure werefor need for kidney transplantpediatric kidney transplant recipientstransplantation

Phase 2

A multi-center interventional study to assess pharmacokinetics, effectiveness and tolerability of prolonged-release Tacrolimus after Paediatric Kidney Transplantation (Pro-Tac)

CompletedCTIS2024-516608-40-00

Universitaetsklinikum Essen AöRCaucasian paediatric kidney transplant recipients

Start: 2022-02-23End: 2026-01-08Target: 30Updated: 2026-01-06

Phase 4

Multicentre, open-label, randomised, two-arm, parallel-group, superiority trial to assess bioavailability and practicability of two once-daily tacrolimus formulations, Envarsus® compared with Advagraf™, administered in kidney transplant recipients

Active, not recruitingCTIS2023-503531-18-00

Universitaetsklinikum RegensburgProphylaxis of transplant rejection in adult kidney allograft recipients

Start: 2024-02-13Target: 300Updated: 2025-08-08

A multi-centre, open, prospective, randomized, parallel-group, 24-month study to compare the outcome of receiving continued immunosuppression versus stopping immunosuppression at 6 months to safely prevent human leukocyte antigen (HLA) sensitization in patients with late renal graft failure

RecruitingCTIS2023-506879-98-00

Vall D'hebron Institut De Recerca, Vall D'hebron Institut De RecercaRenal transplantation

Start: 2024-01-22Target: 202Updated: 2024-09-25

Evaluation of the benefits of Administering immunosuppressive drugs as Single daily doses over the first Year after liver transplantation

RecruitingCTIS2023-506601-19-00

Centre Hospitalier Universitaire De Limogestransplantation

Start: 2025-04-15Target: 200Updated: 2025-10-07

Personalized tacrolimus treatment for pediatric kidney transplant recipients by using a dosing algorithm and a once-daily tacrolimus formulation

Not yet recruitingCTIS2024-511585-36-00

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)pediatric kidney transplant recipients

Target: 28Updated: 2024-06-28

Cognitive function after liver transplantation comparing Tacrolimus formulations

Active, not recruitingCTIS2024-513963-22-00

Universitaetsklinikum Schleswig-Holstein AöRICD 10: Z94.4 Liver transplant status

Start: 2020-12-09Target: 150Updated: 2025-05-19

Multicentre, open-label, randomised, two-arm, parallel-group, superiority study to assess bioavailability and practicability of Envarsus® compared with Advagraf® in de novo liver transplant recipients

Active, not recruitingCTIS2024-518033-28-00

Universitaetsklinikum Regensburg AöRProphylaxis of transplant rejection in adult liver allograft recipients

Start: 2020-11-27Target: 268Updated: 2025-12-03

Personalized Use of Resources Study (PURE)

CompletedCTIS2024-515542-16-03

Stichting Amsterdam UMCkidney failure werefor need for kidney transplant

End: 2025-01-28Target: 25Updated: 2025-01-17