| tacrolimus XR / Generic mfg. |
2009-014670-17: Controlled study on the Relative Pharmacokinetics of Advagraf versus Prograft in Kidney transplant patients with severe Diarrhoea |
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| Ongoing | 4 | 30 | Europe | Tacrolimus capsules, tacrolimus prolonged-release hard capsules, L04AA05, Capsule, hard, Prograf(t) Capsules, advagraf prolonged release hard capsules | H.-Hartziekenhuis Roeselare-Menen vzw | Renal transplant patients suffering from diarrhea | | | | |
2010-021075-89: A MULTICENTER, THREE ARM, RANDOMIZED, OPEN LABEL CLINICAL STUDY TO COMPARE RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT A MONOCLONAL ANTI-IL2R ANTIBODY (BASILIXIMAB) |
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| Ongoing | 4 | 150 | Europe | Capsule, hard, Powder and solvent for solution for injection, Advagraf, Simulect | Astellas Pharma Europe Ltd. | RENAL FUNCTION IN LIVER TRANSPLANT RECIPIENTS RECEIVING AN IMMUNOSUPPRESSIVE REGIMEN OF ADVAGRAF® (IMMEDIATELY OR DELAYED POST-TRANSPLANT) AND MMF WITH OR WITHOUT SIMULECT | | | | |
ChiCTR-ONC-10001519: Multi-center, open-label, non-controlled study of the efficacy and safety of cyclosporine switched to Tacrolimus extended release capsules in renal transplant recipients. |
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| Completed | 4 | 105 | | tacrolimus extended release capsules replacing cyclosporine | People's Liberation Army; Astellas Pharma (China) Co., Ltd., Astellas Pharma (China) Co., Ltd. | renal transplant recipient | | | | |
2012-005652-42: Biomarker after conversion to belatacept mediaction in comparison to standard therapy in renal transplant patients. |
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| Ongoing | 4 | 70 | Europe | Lyophilisate for solution for infusion, Capsule, hard, Tablet, Capsule, soft, Nulojix 250mg, Prograf 1 mg, Prograf 0.5 mg, Prograf 5 mg, Certican 0.1mg, Certican 0.25mg, Certican 0.5mg, Certican 0.75mg, Certican 1 mg, Sandimmun Optoral 10mg, Sandimmun Optoral 25 mg, Sandimmun Optoral 50 mg, Sandimmun Optoral 100 mg, Advagraf 0.5 mg, Advagraf 1 mg, Advagraf 3 mg, Advagraf 5 mg | Charité, Universitätsmedizin Berlin, Bristol-Myers Squibb GmbH & Co. KGaA | Patients after renal transplantation with signs of drug intolerance to their immunsuppressive therapy are considered to be converted to Nulojix, Patients after renal transplantation with signs of drug intolerance to their immunsuppressive therapy are considered to be converted to Nulojix, Not possible to specify | | | | |
| Not yet recruiting | 4 | 140 | Europe | Modified-release capsule, hard, Capsule, Granules for oral solution, Advagraf, Prograf, Modigraf | Oslo University Hospital - Rikshospitalet, OUS-Rikshospitalet | Solid organ transplantation, Impaired organ function, Body processes [G] - Immune system processes [G12] | | | | |
2013-004538-14: Trascriptomic differences between tacrolimus and mTOR inhibitors in the immunosuppressive treatment of renal transplantation Differenze transcrittomiche tra Tacrolimus e inibitori di mTOR nel trattamento immunosoppressivo del Trapianto renale |
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| Ongoing | 4 | 40 | Europe | FK-506, Prolonged-release capsule, Tablet, ADVAGRAF 30CPS 3MG RP, ADVAGRAF 30CPS 0,5 MG RP, ADVAGRAF 60CPS 1MG RP, CERTICAN 60 cpr 0,75 mg, CERTICAN 60 cpr 0,25 mg, RAPAMUNE 100CPR RIV 1MG, RAPAMUNE 30CPR RIV 2MG, MYCOPHENOLATE MOFETIL 50CPR 500MG | Azienda Ospedaliera Universitaria Integrata Verona, Università di Verona | Renal Transplantation Trapianto renale, Renal Transplantation Trapianto renale, Not possible to specify | | | | |
2007-005410-39: “Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” |
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| Ongoing | 4 | 40 | Europe | Advagraf 0,5mg, Genoxal, Dacortín 2,5mg, Advagraf 1mg, Advagraf 5mg, Dacortín 5mg, Dacortín 30mg, Advagraf 0,5mg, Genoxal, Dacortín 2,5mg, Advagraf 1mg, Advagraf 5mg, Dacortín 5mg, Dacortín 30mg | Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología. | La nefropatía membranosa idiopática (NMI) es una enfermedad caracterizada histopatológicamente por un engrosamiento uniforme de la pared de los capilares glomerulares, debido al depósito de complejos inmunes a lo largo del espacio subepitelial, en ausencia de inflamación o cambios proliferativos en el resto del glomérulo. El origen exacto de este trastorno se desconoce sin embargo se sabe que la NMI es una causa frecuente de síndrome nefrótico (SN) del adulto. | | | | |
2009-014050-15: Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant |
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| Ongoing | 4 | 20 | Europe | Tacrolimus capsules, Tacrolimus prolonged-release hard capsules, Prograft capsules, Advagraf prolonged-release hard capsules, Prograft capsules, Advagraf prolonged-release hard capsules | Hopital Erasme - Chest service | Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant | | | | |
2009-013461-25: The influence of CYP3A5 and ABCB1 genotype on the pharmacokinetics of twice daily Tacrolimus and Advagraf |
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| Ongoing | 4 | 330 | Europe | Prograf 0.5, 1 and 5 mg, Advagraf 0.5, 1, 3 and 5mg, Prograf, Advagraf, Prograf, Advagraf | St. George\'s, University of London, Astellas | Renal transplantation. | | | | |
2010-019086-28: Multicenter, no-profit, open, single sequence cross-over study on effectiveness and safety of anti-rejection therapy based on modified release Tacrolimus(Advagraf)and on patients quality of life and adhesion to therapeutical regimen improvement after switch from conventional BID(Prograf) Tacrolimus immunosuppressive therapy to mono-administration of modified release of Tacrolimus in stable kidney transplant recipient |
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| Ongoing | 4 | 210 | Europe | ADVAGRAF*30CPS 0,5MG R.P., ADVAGRAF*30CPS 1MG R.P., ADVAGRAF*50CPS 5MG R.P., ADVAGRAF*30CPS 0,5MG R.P., ADVAGRAF*30CPS 1MG R.P., ADVAGRAF*50CPS 5MG R.P. | UO Divisione Nefrologia, Dialisi e Trapianto renale | Kidney transplant patients | | | | |
2013-000985-13: PRE-transplant pharmacokinetics and Advagraf® Dosing In kidney transplant ReCipienTs Farmacocinética pre-trasplante y dosis de Advagraf® en receptores de trasplanate renal |
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| Ongoing | 4 | 20 | Europe | Advagraf, Advagraf | Astellas Pharma Europe Ltd., Astellas Pharma Europe Ltd. | Prophylaxis of transplant rejection in adult kidney allograft recipients. Profilaxis del rechazo del trasplante en receptores de un injerto renal | | | | |
2015-002465-28: Anti-donor alloreactivity-guided CNI minimization versus unguided standard triple therapy in living-donor kidney transplantation Immunmonitoring-gestützte Minimierung einer Calcineurin-Inhibitor basierten Standard 3-fach Immunsuppression im Vergleich zu einer Medikamentenspiegel orientierten Standardimmunsuppression in der Nierenlebendspendetransplantation |
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| Ongoing | 4 | 100 | Europe | Tacrolimus, Capsule, hard, Advagraf | Klinikum der Universität München, Astellas Pharma GmbH | Renal transplantation Nierentransplantation, Renal transplantation Nierentransplantation, Body processes [G] - Immune system processes [G12] | | | | |
2016-002097-13: Use of tacrolimus in heart transplant recipients Uporaba tacrolimusa pri bolnikih po presaditvi srca |
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| Ongoing | 4 | 70 | Europe | Capsule, Advagraf | Department of Cardiology, University Medical Centre Ljubljana, University Medical Centre Ljubljana | Tacrolimus is a potent immunosuppressant agent widely used for the prevention and treatment of rejection in heart transplant recipients. While tacrolimus is typically administered in two divided doses per day, a new oral formulation with modified-release characteristics has recently been developed and licensed for use. Specifically formulated to enable once daily dosing, it was suggested that the benefit of the prolonged-release preparation maybe improved compliance., While tacrolimus is administered in two doses per day, a new oral formulation with modified-release characteristics has recently been developed and licensed for use possibly improving compliance., Body processes [G] - Immune system processes [G12] | | | | |
ChiCTR1800016648: Clinical Outcome of Delayed or Standard Prograf Together with Induction Therapy Followed by Conversion to Advagraf in DCD Kidney Transplant Recipients: A Randomized, Open-label, Multicenter Clinical Trial |
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| Not yet recruiting | 4 | 300 | | induction therapy + standard Prograf + conversion Advagraf ;induction therapy + delayed Prograf + conversion Advagraf | Tongji Hospital, Tongji Medical College of Huazhong University of Science & Technology; Astellas Pharma China, Inc., Pharmaceutical Enterprise | DCD kidney transplantation. | | | | |
ChiCTR1900020719: To evaluate the efficacy and safety of tacrolimus extended-release capsules and tacrolimus capsules in early postoperative immunosuppression in adult DCD liver transplantation recipients: a single-center, open-label, randomized controlled trial |
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| Recruiting | 4 | 50 | | extended-release tacrolimus ;tacrolimus | Shulan (Hangzhou) Hospital; Shulan (Hangzhou) Hospital, Astellas Pharma China, Inc. | Liver transplantation | | | | |
| Active, not recruiting | 4 | 100 | Europe | Rituximab, Mabthera, Tacrolimus, Advagraf, Adoport, Prograf, Mycophenylate mofetil, MMF, Cellcept, Hydrocortisone, Prednisolone | Guy's and St Thomas' NHS Foundation Trust, Astellas Pharma Europe Ltd. | Function of Renal Transplant | 10/20 | 10/22 | | |
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NCT03216447: A Study of Patient Adherence and Convenience to Immunosuppressive Agents in Newly Liver Transplant |
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| Recruiting | 4 | 150 | RoW | Advagraf, Prograf | Chang Gung Memorial Hospital, Astellas Pharma Taiwan, Inc. | Liver Transplantation | 08/23 | 09/25 | | |
NCT06147648: Early Conversion of Prolonged-release Tacrolimus in Liver Transplantation. |
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| Not yet recruiting | 4 | 352 | NA | Tacrolimus Sustained-release Capsules | Beijing Tsinghua Chang Gung Hospital | Liver Transplantation | 07/25 | 07/26 | | |
ChiCTR2200063697: once-daily immunosuppressive regimen in kidney transplant recipients |
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| Not yet recruiting | 4 | 160 | | Tac-ER+SRL ;Tac+MPA | Tongji Hospital Affiliated to Tongji Medical College, Huazhong University of science and technology; Level of the institution：, NO | kidney transplantation | | | | |
NCT04917718: Renal Tubular Injury and Transplant Outcomes in Cardiac Recipients Converting From IR Tacrolimus to XR Tacrolimus |
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| Recruiting | 4 | 42 | US | Conversion from IR Tacrolimus to XR Tacrolimus | Loyola University, Veloxis Pharmaceuticals | Chronic Kidney Diseases, Heart Transplant | 12/24 | 12/24 | | |
