Advagraf 1 mg prolonged-release hard capsules
Sponsors
Universitaetsklinikum Regensburg, Centre Hospitalier Universitaire De Limoges, Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca, Charite Universitaetsmedizin Berlin KöR, Astellas Pharma Europe Limited
Conditions
Prophylaxis of primary liverProphylaxis of transplant rejection in adult kidney allograft recipientsProphylaxis of transplant rejection in adult liver allograft recipientsRenal transplantationSolid organ transplantation (Kidney)Solid organ transplantation (Liver)advanced chronic renal insufficiencyand intestinal organ transplant rejection
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
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
Use of tacrolimus and MTOR inhibitors with anticipatory therapy vs. tacrolimus and mycophenolic acid with universal prophylaxis in renal recipients at high risk of post-transplant cytomegalovirus. Phase IV clinical trial (TIMTOR STUDY).
Not yet recruitingCTIS2025-520854-12-00
Target: 30Updated: 2026-01-20