Advagraf 0.5 mg prolonged-release hard capsules
Sponsors
Centre Hospitalier Universitaire De Nantes, Universitaetsklinikum Regensburg, Centre Hospitalier Universitaire De Limoges, Vall D'hebron Institut De Recerca, Vall D'hebron Institut De Recerca, Astellas Pharma Europe Limited
Conditions
Kidney transplantKidney transplantationProphylaxis of primary liverProphylaxis of transplant rejection in adult kidney allograft recipientsProphylaxis of transplant rejection in adult liver allograft recipientsRenal transplantationand intestinal organ transplant rejectionheart
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
Start: 2014-03-10End: 2025-11-03Target: 13Updated: 2025-06-12
Immunosuppression regimen reduction in kidney transplantation recipients admitted to the intensive care unit in the setting of septic shock and/or acute respiratory failure: an open multicentric randomized phase IV study
Not yet recruitingCTIS2024-518493-14-00
Target: 212Updated: 2025-11-19
Phase 3
Prospective, multicenter, randomized, open-label, parallel-group controlled phase 3 study of tacrolimus minimization in kidney transplant recipients selected according to the AGORA algorithm for their low immunological risk and medium-term graft failure
RecruitingCTIS2022-502624-44-00
Start: 2024-12-10Target: 343Updated: 2024-10-21
Screening for subclinical antibody mediated rejection and efficacy of belatacept in the context of de novo donor specific antibody after kidney transplantation / BEL-AMR
Not yet recruitingCTIS2024-516527-13-00
Target: 290Updated: 2025-06-24
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
TRANSPGx: A multicentre, controlled, randomised and single-blind, adaptive phase IV protocol to evaluate effectiveness and cost-effectiveness of pre-emptive genotyping strategy to optimise tacrolimus dosage in a pretransplant chronic kidney disease population cohort
RecruitingCTIS2024-516596-32-00
Start: 2025-03-31Target: 114Updated: 2025-08-08