13 completed, 3 unknown, 1 withdrawn. 17 Phase 3, 2 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 17 | Completed 13, Unknown 3, Withdrawn 1 |
| Phase 2 | 2 | Completed 1, Unknown 1 |
Follow Advagraf: new trials by email Literature Review of Advagraf trials Research Report on Advagraf
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Sirolimus-based Immunosuppression Treatment Regimen for Liver Transplantation Tacrolimus, Tacrolimus (Tacrolimus elimination), Sirolimus - Liver Transplantation | Phase 2 / Phase 3 | Unknown | Southern Medical University, China | 130 | 2018-05-01 | 2018-04-18 |
| Incidence of Non Adherence to Treatment With Once-daily Formulation of Tacrolimus Tacrolimus BID, Advagraf QD - Medication Adherence | Phase 3 | Unknown | Rabin Medical Center | 60 | 2016-08-01 | 2016-07-12 |
| Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen Advagraf - Renal Failure, Renal Insufficiency | Phase 3 | Unknown | Technische Universität Dresden | 400 | 2014-09-01 | 2022-08-03 |
| Prograf-Advagraf Cross Over Conversion Study Tacrolimus - Kidney-Pancreas Transplantation | Phase 3 | Completed | University Health Network, Toronto | 13 | 2013-06-01 | 2014-09-18 |
| Conversion of Prograf to Advagraf in Pediatric Renal Transplant Recipients tacrolimus - Kidney Transplantation, Pediatric Patients | Phase 2 / Phase 3 | Completed | Seoul National University Hospital | 2011-07-01 | 2015-05-27 | |
| Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis ADVAGRAF - Lupus Nephritis | Phase 3 | Withdrawn | Sun Yat-sen University | 2011-01-01 | 2014-02-12 | |
| The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS) Tacrolimus Sustained-release Capsules (ADVAGRAF) - Nephrotic Syndrome | Phase 3 | Completed | Sun Yat-sen University | 20 | 2011-01-01 | 2011-11-02 |
| Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation Advagraf, Mycophenolate Mofetil, Basiliximab - Liver Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 893 | 2009-09-30 | 2024-11-01 |
| Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts tacrolimus, Simulect, Cellcept - Kidney Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 281 | 2009-08-17 | 2024-11-01 |
| A Study to Evaluate and Compare the Efficacy and Safety of FK506MR vs Prograf® in Stable Liver Transplantation Patients Prograf, FK506MR capsule - Liver Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 172 | 2008-01-01 | 2016-02-24 |
| Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients Tacrolimus (reduced tacrolimus), Tacrolimus (tacrolimus elimination), Tacrolimus (tacrolimus control) - Liver Transplantation | Phase 3 | Completed | Novartis Pharmaceuticals | 719 | 2008-01-01 | 2013-05-27 |
| An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients Tacrolimus, modified release - Kidney Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 27 | 2007-09-01 | 2014-07-18 |
| A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Kidney Transplantation FK506MR, Prograf, Mycophenolate Mofetil - Kidney Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 240 | 2007-07-01 | 2016-02-24 |
| Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects tacrolimus - Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 346 | 2007-04-01 | 2014-07-18 |
| A Study to Compare the Efficacy and Safety of FK506MR vs Prograf® in Patients Undergoing Liver Transplantation Tacrolimus modified-release, Prograf - Liver Transplantation | Phase 3 | Completed | Astellas Pharma Inc | 42 | 2007-03-01 | 2016-02-24 |
| Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection Alemtuzumab, Tacrolimus - Kidney Transplantation | Phase 3 | Completed | Dr. Claudia Bösmüller | 197 | 2004-01-01 | 2012-06-19 |
| Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant FK506E - Heart Transplantation, Liver Transplantation | Phase 3 | Completed | Astellas Pharma Europe Ltd. | 850 | 2003-02-24 | 2024-11-22 |
Medication Adherence (2) · Kidney Diseases (1) · Lupus Nephritis (1) · Nephrotic Syndrome (1) · Renal Insufficiency (1) · Renal Insufficiency, Chronic (1)
Astellas Pharma Inc (7) · Sun Yat-sen University (2) · Astellas Pharma Europe Ltd. (1) · Dr. Claudia Bösmüller (1) · Novartis Pharmaceuticals (1) · Rabin Medical Center (1) · Seoul National University Hospital (1) · Southern Medical University, China (1) · Technische Universität Dresden (1) · University Health Network, Toronto (1)
China (6) · Canada (5) · Germany (5) · Austria (4) · Belgium (4) · Czechia (4) · France (4) · Hungary (4) · Italy (4) · Spain (4) · Sweden (4) · Brazil (3) · Finland (3) · Ireland (3) · Netherlands (3)
Yu Xueqing, MD (2) · Christian Hugo, MD, PhD (1) · Eyan Mor, MD (1) · Jongwon Ha, MD, PhD (1) · Kebo Zhong, M.D (1) · Mark S Cattral, MD (1) · Prof. Ao Jianhua (1) · Prof. Leng Xisheng (1) · Raimund Margreiter, Prof. Dr. (1)
PMID 18510632, PMID 22211928, PMID 23714399, PMID 26151607, PMID 28817434, PMID 30582281, PMID 36094829, PMID 39082471, PMID 39739990
2005 (1), 2008 (1)