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Advagraf 1 mg prolonged-release hard capsules

DRUG9 trials

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

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
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
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
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
Hospital Universitario La Pazadvanced chronic renal insufficiency
Target: 30Updated: 2026-01-20