Envarsus 1 mg prolonged-release tablets
Sponsors
Universitaetsklinikum Regensburg, Centre Hospitalier Universitaire De Limoges, Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca, Charite Universitaetsmedizin Berlin KöR, Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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 transplantationSolid organ transplantation (Kidney)Solid organ transplantation (Liver)kidney failure werefor need for kidney transplant
Phase 1
A Phase I/IIa open label single ascending dose study to investigate the safety and tolerability of regulatory T cells as an adjunctive therapy in deceased-donor kidney recipients - ProTreg
RecruitingCTIS2024-514398-23-00
Start: 2024-06-10Target: 27Updated: 2025-09-10
A Phase I/IIa open label single ascending dose study to assess safety and tolerability of regulatory T cells to promote discontinuation of tacrolimus monotherapy in liver transplant recipients - LiveTreg
RecruitingCTIS2023-508261-32-00
Start: 2025-07-21Target: 27Updated: 2025-08-14
Phase 2
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
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
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
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
Target: 28Updated: 2024-06-28
Cognitive function after liver transplantation comparing Tacrolimus formulations
Active, not recruitingCTIS2024-513963-22-00
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
Start: 2020-11-27Target: 268Updated: 2025-12-03
Personalized Use of Resources Study (PURE)
CompletedCTIS2024-515542-16-03
End: 2025-01-28Target: 25Updated: 2025-01-17