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Advagraf 3 mg prolonged-release hard capsules

DRUG5 trials

Sponsors

Universitaetsklinikum Regensburg, Centre Hospitalier Universitaire De Limoges, Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca, Astellas Pharma Europe Limited, Universitaetsklinikum Regensburg AöR

Conditions

Prophylaxis of primary liverProphylaxis of transplant rejection in adult kidney allograft recipientsProphylaxis of transplant rejection in adult liver allograft recipientsRenal transplantationand intestinal organ transplant rejectionheartkidneylung

Phase 2

A Phase II, Open-Label, Multi-Center Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted from a Prograf® Based Immunosuppressive Regimen to a Tacrolimus Prolonged Release, Advagraf® Based Immunosuppressive Regimen, Including a Long-Term Follow Up
CompletedCTIS2024-513546-11-00
Astellas Pharma Europe Limitedand intestinal organ transplant rejection, heart, kidney +2
Start: 2014-03-10End: 2025-11-03Target: 13Updated: 2025-06-12

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