tacrolimus intravenous / Generic mfg. |
2008-000252-28: A Multi-Centre Prospective Controlled Trial Comparing Calcineurin Inhibitor Monotherapy With Sirolimus Monotherapy in Hepatitis C Infected Patients with Hepatic Fibrosis Following Liver Transplantation |
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| Ongoing | 4 | 120 | Europe | Neoral, Coated tablet, Capsule, hard, Capsule, soft, Rapamune, Prograf, Neoral | Cambridge University Hospitals NHS Foundation Trust | Patients who have undergone liver transplantation and are infected with Hepatitis C virus. | | | | |
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 | | | | |
ChiCTR-TRC-09000593: The Efficacy and safety of pretreatment with Prograf in living donor kidney transplantation |
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| Completed | 4 | 230 | | Prograf (routine)+MMF+corticosteroids ;Prograf (pretreatment)+Progrof (routine)+MMF+corticosteroids | 309 Hospital of Chinese PLA; Astellas Pharma China, Inc., Astellas Pharma China, Inc. | living donor kidney transplantation | | | | |
ChiCTR-TRC-11001144: A Prospective Randomized Study on the Efficacy of Steroid combined with CTX or Tacrolimus in IMN Patients with NS |
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| Recruiting | 4 | 60 | | CTX 0.5-0.75g/m2, max 1g, pred 1mg/kg/d <65y, Max 70mg/d; >65y, pred 0.5mg/kg/d; for 12 months ;FK506 0.1mg/kg/d, for 12months, pred 0.5mg/kg/d | Shanghai Jiaotong University Affiliated Ruijin Hospital; anghai Jiaotong University Affiliated Ruijin Hospital, Shanghai Jiaotong University Affiliated Ruijin Hospital | Idiopathic membranous nephropathy | | | | |
2012-001909-24: Pharmacokinetics of tacrolimus in the first days after heart and lung transplantation Farmacokinetiek van tacrolimus in de eerste dagen na hart en long transplantatie |
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| Ongoing | 4 | 30 | Europe | tacrolimus, RVG222236 and RVG18107, Capsule, hard, Prograft®, tacrolimus | University Medical Center Utrecht, University Medical Center Utrecht | Heart and lung transplantation, first days after transplantation Hart en long transplantatie, eerste dagen na transplantatie, Heart and lung transplantation, first days after transplantation Hart en long transplantatie, eerste dagen na transplantatie, Body processes [G] - Physical Phenomena [G01] | | | | |
ChiCTR-TRC-10001024: Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis |
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| Completed | 4 | 60 | | intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d | Shanghai Jiaotong University Affiliated Ruijin Hospital; Level of the institution:, Shanghai Jiaotong University Affiliated Ruijin Hospital | primary focal segmental glomerulosclerosis | | | | |
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] | | | | |
2013-000615-24: Optimization of tacrolimus dose regimen in pediatric living donor liver transplantation. Optimisation de la prescription du tacrolimus en transplantation hépatique pédiatrique à donneur vivant. |
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| Ongoing | 4 | 50 | Europe | Capsule, Granules for oral suspension in sachet, Prograft, Modigraf | Cliniques universitaires Saint-Luc, Cliniques universitaires SAINT-LUC | PEDIATRIC LIVER TRANSPLANTATION Transplantation hépatique pédiatrique, PEDIATRIC LIVER TRANSPLANTATION Transplantation hépatique pédiatrique, Body processes [G] - Immune system processes [G12] | | | | |
| Recruiting | 4 | 120 | | MMF 0.75~1.0g/d in induction stage, MMF0.5~0.75g/d in maintenance stage ;FK506 0.1mg/kg/d in induction stage, FK506 0.05mg/kg/d in maintenance stage ;Intravenous CYC was given in monthly pulses of 0.5-0.75g/m2 in induction stage, Aza 1-2mg/kg/d in maintenance stage | Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai, China; Level of the institution:, Self-financing | Active lupus nephritis | | | | |
2004-005055-33: Evaluating the safety and efficacy of mycophenolate mofetil, daclizumab and a single, initial week of corticosteroids in combination with tacrolimus or sirolimus with continued steroid as mainstay immunosuppression in comparison to current standard immunosuppression (mycophenolate mofetil, tacrolimus and continued corticosteroids) in renal transplantation. |
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| Ongoing | 4 | 180 | Europe | Zenapax, Cellcept, Prograf, Rapamune, Ro 24-7375, Ro 106-1443, Not available, Zenapax, Cellcept, Prograf, Rapamune, Zenapax, Cellcept, Prograf, Rapamune | Barts and the London NHS Trust | Renal Transplantation | | | | |
2005-002266-10: Estudio para comparar la evolución de la hepatitis C con ciclosporina C2 frente a tacrolimus en receptores de trasplante hepático de novo virus C positivos.Study to compare hepatitis C evolution with ciclosporin C2 versus tacrolimus with patients virus C positive who have received a liver transplantation de novo. |
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| Ongoing | 4 | 246 | Europe | Sandimmun Neoral, Prograf, FK506, Sandimmun Neoral, Prograf, Sandimmun Neoral, Prograf | Dr. Evaristo Varo Pérez | Trasplante hepático | | | | |
2007-000541-35: Etude pilote de comparaison de la méthode EMIT et de la chromotographie liquide couplée à la spectométrie de masse pour l\'étude de la pharmacocinétique du mycophénolate mofétil chez des patients transplantés hépatiques de novo. |
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| Ongoing | 4 | 20 | Europe | Cellcept, Porgraf, Solupred, cellcept, Cellcept, Prograf, Solupred, cellcept, Cellcept, Prograf, Solupred, cellcept | Centre Hospitalier Universitaire de Montpellier | transplantation hépatique | | | | |
2006-005774-50: Protocol for taking pharmacogenetic testing of tacrolimus into the clinical arena: patient tailored anti-rejection therapy |
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| Ongoing | 4 | 400 | Europe | Prograf, Prograf | Central Manchester & Manchester Children\'s University Hospitals NHS Trust | The study is to determine whether MDR-1 genotyping correlates with tacrolimus dose in individual patients and could therefore be used in future to predict tacrolimus dose. All patients will have undergone or be about to undergo a kidney transplant and require treatment with tacrolimus immunosuppression. | | | | |
2007-000789-19: Withdrawal of Calcineurin Inhibitors (CNIs) during administration of Mycophenolate Mofetil (MMF) in liver transplant patients suffering adverse effects from CNIs: Study of the reduction in rejection risk by therapeutic drug monitoring of Mycophenolate Mofetil |
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| Ongoing | 4 | 130 | Europe | Cellcept, Neoral-Sandimmun, Prograft, Cellcept, Neoral-Sandimmun, Prograft | CHU de Liège, Domaine Universitaire du Sart Tilman | liver transplant patients suffering adverse effects from treatment with calcineurin inhibitors | | | | |
2007-002763-27: A multi-center, randomized, controlled trial with programmed introduction of Sirolimus-based, Calcineurin inhibitor free immunosuppression in recipients of non-heart-beating donor kidney grafts. |
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| Ongoing | 4 | 100 | Europe | Sirolimus, Tacrolimus, Rapamune, Prograft, Rapamune, Prograft | Erasmus MC | Recipients of a renal allograft from a non-heart-beating donor, three months after transplantation. | | | | |
2006-004773-99: A RANDOMISED CONTROLLED TRIAL COMPARING THE USE OF SIROLIMUS BASED BIPHASIC IMMUNOSUPRESSION WITH MYFORTIC TO ALLOW EARLY CNI WITHDRAWAL IN RENAL TRNASPLANTATION |
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| Ongoing | 4 | 42 | Europe | Rapamune, Rapamune, Prograf, Myfortic, Rapamune, Prograf, Myfortic | University Hospitals Leicester | Chronic Allograft Nephropathy | | | | |
2008-001501-42: Tacrolimus in the treatment of Painful Bladder Syndrome / Interstitial Cystitis |
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| Ongoing | 4 | 10 | Europe | Prograf | Jukka Sairanen | Painful bladder syndrome / interstitial cystitis (PBS/IC) | | | | |
2007-003649-34: RENAL RESCUE IMMUNOSUPPRESSION FOLLOWING HEART TRANSPLANTATION |
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| Ongoing | 4 | 56 | Europe | Mycophenolic acid, Ciclosporin, Tacrolimus, Azathioprine, Mycophenolate mofetil, Myfortic, Neoral, Prograf, Cellcept, Myfortic, Neoral, Prograf, Cellcept | University Hospital of South Manchester NHS Foundation Trust | Renal impairment following heart transplantation | | | | |
2007-003023-20: TACROLIMUS – DACLIZUMAB - MYCOPHENOLATE MOFETIL IMMUNE PROPHYLAXISIN PEDIATRIC LIVER TRANSPLANTATION. An open, pilot, investigator-driven study in 20 recipients |
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| Ongoing | 4 | 50 | Europe | Prograft, Cellcept, Zenapax, Prograft, Cellcept, Zenapax | Cliniques universitaires Saint-Luc | Liver transplantation | | | | |
2008-000627-26: Conversion from cyclosporine to tacrolimus followed by randomized C0 or Bayesian monitoring using the C4 timepoint The effect on kidney function |
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| Ongoing | 4 | 50 | Europe | Prograft, Prograf(t), Prograf(t) | Leiden University Medical Center | Effect of immunosuppressive medication on renal function following livertransplantation | | | | |
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 | | | | |
2009-014436-38: A prospective, open, randomized, single center study comparing the effects of duo therapy with Everolimus and steroids versus triple treatment of low dose calcineurin inhibitor, low-dose MMF and steroids at least one year after renal transplantation.Effects on renal function, tolerability, chronic allograft damage, cardiovascular parameters and malignancies. |
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| Ongoing | 4 | 130 | Europe | Certican, Neoral, Prograft, Mycofenolaat mofetil, Prednisolon 5 PCH, Certican, Neoral, Prograft, Mycofenolaat mofetil CF 500, Prednisolon 5 PCH, Certican, Neoral, Prograft, Mycofenolaat mofetil CF 500, Prednisolon 5 PCH | UMCG | Renal transplantation. | | | | |
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. | | | | |
2010-018917-30: A SINGLE-CENTER PHARMACOGENETIC STUDY OF DONOR AND RECIPIENT TO IMPROVE THE EFFICACY AND REDUCE THE NEPHROTOXICITY OF TACROLIMUS AFTER KIDNEY TRANSPLANTATION |
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| Ongoing | 4 | 250 | Europe | Prograft, Prograft, Prograft | Erasmus Medical Center | Kidney transplantation | | | | |
2010-019398-14: IMPROVEMENT OF RENAL FUNCTION BY CONVERSION OF TACROLIMUS TO EVEROLIMUS 3 MONTHS AFTER KIDNEY TRANSPLANTATION |
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| Ongoing | 4 | 250 | Europe | Certican, Prograft, L04AD02, Certican, Prograft, Certican, Prograft | Erasmus Medical Center | Kidney 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 | | | | |
2013-000766-11: Etude pilote, prospective, multicentrique, randomisée, en ouvert, comparant deux protocoles d’immunosuppression utilisant en traitement d’induction : soit un anticorps monoclonal antirécepteur de l’Interleukine 2 (Simulect®), soit des globulines antilymphocytaires (ATG® Frésénius), associés à une trithérapie Prograf®, Myfortic® et corticoïdes, pour la prévention du rejet chez les adultes transplantés rénaux immunisés de novo. |
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| Ongoing | 4 | 60 | Europe | ATG® frésénius, Simulect® (Basiliximab), ATG® frésénius, Simulect® (Basiliximab) | CHU Toulouse, FRESENIUS, NOVARTIS | Prévention du rejet chez les adultes transplantés rénaux | | | | |
2008-005925-12: Polyomavirus BK nephropathy after renal transplantation: Randomized clinical trial to demonstrate that switching to mTOR inhibitor is more effective than a reduction of immunosuppressive therapy |
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| Ongoing | 4 | 120 | Europe | Everolimus 0.25 mg, Cyclosporin 100 mg, Tacrolimus 0.5 mg, Everolimus 0.75, Everolimus 1.0 mg, Cyclosporin 25 mg, Cyclosporin 50 mg, Everolimus 0.5 mg, Cyclosporin 10 mg, Tacrolimus 1.0 mg, Tacrolimus 5 mg, 001773-Z913, Certican 0.25mg, Sandimmun 100 mg, Prograf 0.5 mg, Certican 0.75mg, Certican 1.00 mg, Sandimmun 25 mg, Sandimmun 50 mg, Certican 0.5mg, Sandimmun 10 mg, Prograf 1.0 mg, Prograf 5 mg, Certican 0.25mg, Sandimmun 100 mg, Prograf 0.5 mg, Certican 0.75mg, Certican 1.00 mg, Sandimmun 25 mg, Sandimmun 50 mg, Certican 0.5mg, Sandimmun 10 mg, Prograf 1.0 mg, Prograf 5 mg | Medizinische Hochschule Hannover | Polyoma BK-virus nephropathy is a viral complication after renal transplantation attacking up to 10% of renal transplants and causing transplant failure in 45% of cases. No virustatic treatment exists. Modifying the infection is usually tried by lowering immunosuppression, which may lead to transplant failure by rejection as well. A randomized switch of immunosuppression to everolimus vs general lowering of immunosuppression has to be tested (prospect. random. parallel group comparison). | | | | |
ChiCTR-OIB-16007789: 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation |
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| Recruiting | 4 | 30 | | 0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days | Eye Institute of Xiamen University; Eye Institute of Xiamen University, Senju Pharmaceutical Co., Ltd. | Sjogren's syndrome | | | | |
2015-005559-29: Fluctuations in tacrolimus levels in renal transplant patients treated with different tacrolimus formulations. |
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| Ongoing | 4 | 120 | Europe | Prograft, Advagraf, Envarsus, Capsule, Tablet, Prograft, Advagraf, Envarsus | Erasmus MC, Chiesi | kidney transplantation, kidney transplantation, Body processes [G] - Immune system processes [G12] | | | | |
2016-002519-17: The behaviour of the drug tacrolimus in the stomach of healthy volunteers Het gedrag van het geneesmiddel tacrolimus in de maag van gezonde vrijwilligers |
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| Ongoing | 4 | 10 | Europe | Prograft, Tacrolimus Accord, RVG 102496-102497, Capsule, hard, Prograft, Tacrolimus Accord | KU Leuven - Drug Delivery and Disposition, KU Leuven | Healthy human volunteers , investigation of the drug's supersaturation behaviour in the stomach Gezonde vrijwilligers, onderzoek naar het supersaturatie gedrag van het geneesmiddel in de maag, Healthy volunteers, investgation of the drug behaviour in the stomach Gezonde vrijwilligers, onderzoek naar het gedrag van het geneesmiddel in de maag., Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | | | | |
ChiCTR-IPQ-15006773: 0.1% tacrolimus (FK506) in the treatment of moderately severe dry eye clinical efficacy evaluation |
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| Recruiting | 4 | 50 | | 0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days ;0.5% of chlorine for spilt + 0.1% sodium hyaluronate Twice a day for 30 days ;0.1%FK506+0.5%Chloromethyl+0.1%Sodium hyaluronate Twice a day, every time a drop, 30 days | Eye Institute of Xiamen University; Eye Institute of Xiamen University, Senju Pharmaceutical Co., Ltd. | dry eye | | | | |
2017-000718-52: A pilot study to prevent post- renal trasplant diabetes in patients at risk Estudio piloto para prevenir la diabetes porst-transplante en pacientes de riesgo |
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| Ongoing | 4 | 50 | Europe | ENVARSUS, prograf, Tablet, ENVARSUS, Prograf | Hospital Universitario de Canarias, Chiesi Farmaceutici S.p.A. | diabetes post-renal trasnplant diabetes post-trasplante renal, diabetes afer a renal trasnplant diabetes tras transplante renal, Body processes [G] - Metabolic Phenomena [G03] | | | | |
2018-000011-25: Avoiding tacrolimus under- and overexposure by using a dosing guideline for the starting dose of tacrolimus following kidney transplantation Het voorkomen van onder- en overdosering van tacrolimus na niertransplantatie door de startdosering van tacrolimus te berekenen met een doseer richtlijn |
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| Ongoing | 4 | 60 | Europe | Prograft, Capsule, Prograft | Erasmus MC, Stichting de Merel | kidney transplantation nier transplantatie, kidney transplantation nier transplantatie, Body processes [G] - Immune system processes [G12] | | | | |
2018-001290-24: Manifestation of a certain form of genes after administration of the drug substance "tacrolimus" in patients after liver transplantation, and its connection to clinical events Die Entfaltung einer bestimmten Art von Genen nach Einnahme des Arzneistoffs "Tacrolimus" nach Lebertransplantationen; und dessen Zusammenhang zu klinischen Ereignissen |
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| Ongoing | 4 | 21 | Europe | Prograf 0,5 mg Hartkapseln, Prograf 1 mg Hartkapseln, Prograf 5 mg Hartkapseln, Prograf 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Tacni 0,5 mg Hartkapseln, Tacni 1,0 mg Hartkapseln, Tacni 5,0 mg Hartkapseln, Advagraf 0,5 mg Hartkapseln, retardiert, Advagraf 1,0 mg Hartkapseln, retardiert, Advagraf 3,0 mg Hartkapseln, retardiert, Advagraf 5,0 mg Hartkapseln, retardiert, Envarsus 0,75 mg Retardtabletten, Envarsus 1,0 mg Retardtabletten, Envarsus 4,0 mg Retardtabletten, Capsule, hard, Concentrate for solution for infusion, Tablet, Prograf 0,5 mg Hartkapseln, Prograf 1 mg Hartkapseln, Prograf 5 mg Hartkapseln, Prograf 5 mg/ml Konzentrat zur Herstellung einer Infusionslösung, Tacni, Advagraf, Envarsus | Medical University of Graz, Medical University of Graz | Immunosuppression after liver transplantation Immunsuppression nach Lebertransplantation, Suppression of the immune system after liver transplantation Unterdrückung des Immunsystems nach Lebertransplantation, Body processes [G] - Immune system processes [G12] | | | | |
2019-002539-27: Association between tacrolimus levels and development of toxicity in the kidneys of renal transplant recipients |
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| Not yet recruiting | 4 | 40 | Europe | Prograf, 301601, Capsule, Prograf | Oslo University Hospital – Rikshospitalet, Oslo University Hospital – Rikshospitalet | Development of renal interstitial fibrosis in renal transplant recipients, Development of kidney toxicity in renal transplant recipients, Not possible to specify | | | | |
ChiCTR1800015689: Clinical study of traditional Chinese medicine Yushen reciption in the intervention of early chronic allograft nephropathy |
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| Not yet recruiting | 4 | 80 | | CNI (CsA/FK506 + MMF + Pred) plus Yushen Recipe ;CNI (CsA/FK506 + MMF + Pred) | Shanghai General Hospital; Shanghai General Hospital, Shanghai Municipal Commission of Health and Family Planning,Shanghai Municipal Office for Development of Traditional Chinese Medicine | chronic allograft nephropathy | | | | |
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. | | | | |
NCT03511560: Envarsus on the Effect of Total Tacrolimus Dose/Trough Level Ratio on Renal Function (eGFR) in Kidney Transplantation |
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| Active, not recruiting | 4 | 50 | US | Tacrolimus Extended Release Oral Tablet, Envarsus XR, Tacrolimus, Prograf | Columbia University, Veloxis Pharmaceuticals | Renal Transplant Rejection, Kidney Transplant Failure and Rejection | 07/20 | 07/21 | | |
ChiCTR1900022169: A randomized controlled study for comprehensive treatment of proliferative allergic conjunctivitis |
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| Not yet recruiting | 4 | 200 | | Treatment with FK506 ;Treatment with 0.1% Flurometholone ;Treatment with Fk506 + Azelastine eye drops ;Treatment with 0.1%Flurometholone+Azelastine Hydrochloride eye drop | Eye and ENT Hospital of Fudan University; Eye and ENT Hospital of Fudan University, Research funds | Allergic conjunctivitis | | | | |
2019-004946-13: Conversion to extended-release MeltDose® tacrolimus after kidney transplantation - impact on glucose metabolism and lipid profile |
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| Not yet recruiting | 4 | 50 | Europe | Prograf, Prolonged-release tablet, Envarsus, prograf | Univeristy Hospital Tuebingen, Chiesi GmBh | stable adult kidney transplant, stable adult kidney transplant, Body processes [G] - Metabolic Phenomena [G03] | | | | |
2019-002476-14: Interaction between bacteria in the intestines and immunosuppressive drugs |
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| Not yet recruiting | 4 | 100 | Europe | Capsule, hard, Tablet, Prograf, CellCept | Oslo University Hospital - Rikshospitalet, Oslo University Hospital - Rikshospitalet | Kidney transplantation, Patients above 18 years transplanted with a kidney from either a living- or deceased donor, Diseases [C] - Immune System Diseases [C20] | | | | |
| 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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NCT02837978: The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment |
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| Completed | 4 | 150 | RoW | Tacrolimus, FK506, MTX, methotrexate | Qiang Shu | Arthritis, Rheumatoid | 09/22 | 12/22 | | |
NCT02866682: Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients |
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| Completed | 4 | 176 | US | Prograf, Tacrolimus | University of California, Los Angeles, Food and Drug Administration (FDA) | Renal Transplant Rejection | 06/21 | 06/21 | | |
NCT04009525: Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major: A Multicenter, Prospective Clinical Study |
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| Recruiting | 4 | 800 | RoW | Busulfan, Bu, Cyclophosphamide, Cy, Fludarabine, Flu, Thymoglobulin, ATG, cyclosporine A, CsA, Mycophenolate mofetil, MMF, Tacrolimus, FK506, Methotrexate, MTX, Basiliximab, Simulect, Ruxolitinib | First Affiliated Hospital of Guangxi Medical University, Peking University People's Hospital, Ruijin Hospital, The 923th Hospital of People's Liberation Army, Fourth Affiliated Hospital of Guangxi Medical University, Liuzhou General Hospital, Hainan General Hospital, The Affiliated Hospital Of Guizhou Medical University, The First People's Hospital of Yunnan | Thalassemia Major | 05/22 | 05/23 | | |
NCT02081755: Safety and Efficacy of Everolimus Treatment in Liver Transplantation for Liver Cancer |
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| Active, not recruiting | 4 | 336 | US | Everolimus, Zortress, Afinitor, Tacrolimus, Prograf, Myfortic, Mycophenolic Acid, CellCept, Mycophenolate Mofetil, Imuran, Azathioprine | Baylor Research Institute | Carcinoma, Hepatocellular | 06/24 | 06/24 | | |
| Completed | 4 | 44 | Europe | LCP-tacrolimus, Envarsus®, twice-daily tacrolimus, Prograf® | University Hospital Tuebingen | Posttransplant Diabetes Mellitus | 08/23 | 12/23 | | |
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 | | |
PTAAK, NCT03841097: Pulse Wave Velocity, Tacrolimus Time in Therapeutic Range and CV in African American Kidney Transplants |
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| Recruiting | 4 | 60 | US | Extended Release Tacrolimus Tablets, LCPT, Envarsus XR®, Immediate Release Tacrolimus Capsule, IR-TAC, Prograf® | Roy D. Bloom, MD, Veloxis Pharmaceuticals | Kidney Transplant; Complications | 03/25 | 09/25 | | |
OPERATOR, NCT04838288: Cognitive Outcomes in Stable Renal Transplant Patients Switched fromTacrolimus to Envarsus XR™ |
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| Recruiting | 4 | 60 | US | Change from Prograf to Envarsus XR, Change from Tacrolimus to Envarsus XR | Vanderbilt University Medical Center, Veloxis Pharmaceuticals | Renal Transplant | 06/24 | 06/24 | | |
NCT05655273: Conversion of Maintenance Prograf to Envarsus in Liver Transplant Recipients |
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| Enrolling by invitation | 4 | 40 | Canada | Prograf, Envarsus | University Health Network, Toronto, Paladin Labs Inc. | Liver Transplant Rejection, Immune System Suppression | 04/25 | 02/26 | | |
NCT05242315: Extended-Release Tacrolimus Following Liver Transplantation |
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| Recruiting | 4 | 94 | Canada | Envarsus Oral Product, Prograf (SOC) | University of Alberta | Liver Transplant; Complications, Renal Insufficiency, Immunosuppressant Adverse Reaction, Metabolic Syndrome, Cardiovascular Diseases | 07/25 | 02/34 | | |
LCP-TAC, NCT05089604: Tacrolimus Associated Tremors in Liver Transplantation: Immediate-Release Versus Extended-Release Formulations |
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| Recruiting | 4 | 124 | Canada | Tacrolimus, Immediate Release, Oral, Tacrolimus, Sandoz, Prograf, Tacrolimus Extended Release Oral Tablet, Envarsus | University of British Columbia, Paladin Labs Inc. | Liver Transplantation, Immunosuppression, Neurotoxicity, Tremor, Tacrolimus | 01/26 | 12/26 | | |
NCT02630628: Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis |
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| Active, not recruiting | 4 | 130 | RoW | Tacrolimus, Prograf, Mycophenolate mofetil, Cellcept | The University of Hong Kong | Lupus Nephritis | 01/25 | 01/25 | | |
ChiCTR2300073330: A prospective, single-arm, open, multicenter clinical trial of complement protein C5 monoclonal antibody bridging allogeneic hematopoietic stem cell transplantation for PNH |
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| Not yet recruiting | 4 | 20 | | Pretreatment scheme for full-sib compatibility: C5 McAb 600 mg for -9 days.Fludarabine (FLU) 30 mg/m2/d x 6 d (-7 to -2D) + CY 50 mg/kg/d x 2D (-4 to -3D) + ATG 2.5mg/kg/d x 5 d (-8 to -4D). ;Alternative donor (unrelated donor, haplotype donor) conditioning regimen: C5 McAb 600 mg for -9 days. Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) x 2D (-7 to -6d) + cyclophosphamide (CY) 50 mg/kg/d x 4D (-5 to -2D) + ATG 2.5 mg/kgd x 4D (-5 to -2D). ;Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1-2 mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc. Hormone reduction as appropriate ;Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units. ;Other concomitant therapy: For hemoglobin < 60 g/L or red blood cell transfusion therapy is allowed in emergency. Hormones are allowed to control acute hemolysis, hematopoietic and erythropoietic drugs are allowed, and G-CSF can be used when neutrophils are less than 1 x 10^9/L. In the case of organ dysfunction, the use of drugs to protect organs is allowed. Anti-infective drugs are permitted in the presence of infection. | Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-funded | Classic PNH and PNH with bone marrow failure | | | | |
ChiCTR2300074009: Prospective, single-arm, open, multicenter clinical trial of monoclonal antibody to complement protein C5 for the prevention of GVHD after haplotype hematopoietic stem cell transplantation for SAA |
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| Not yet recruiting | 4 | 20 | | Haplotype transplantation pretreatment protocol: Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) × 2D (-7 to - 6d) + cyclophosphamide (CY) 50 mg/kg/d × 4D (-5 to -2D) + ATG 2.5 mg/kgd × 4D (- 5 to -2D). Application of C5 monoclonal antibody: 1 dose (600 mg) on day + 7 after transplantation. Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1 ~ 2mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc.Hormone reduction as appropriate. Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units. Transfusion of red blood cells is allowed for hemoglobin < 60g/L or emergency treatment.Hormones are allowed to control acute hemolysis, hematopoietic and erythropoietic drugs are allowed, and G-CSF can be used when neutrophils are less than 1 × 109/L.When organ function damage occurs, it is allowed to use drugs to protect organs.Anti-infective drugs are permitted in the presence of infection | Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-financing | Haplotype hematopoietic stem cell transplantation for SAA | | | | |
ChiCTR2300073329: Prospective, open, multicenter clinical trial of complement protein C5 monoclonal antibody and allogeneic hematopoietic stem cell transplantation for PNH |
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| Not yet recruiting | 4 | 90 | | C5 McAb 600 mg was administered once a week for 4 weeks, and C5 McAb 900 mg was administered once every two weeks from the fifth week, and then long-term administration. ;Pretreatment scheme for full-sib compatibility: Fludarabine (FLU) 30 mg/m2/d x 6 d (- 7 to -2D) + CY 50 mg/kg/d x 2D (-4 to -3D) + ATG 2.5 mg/kg/d x 5d (-8 to -4D). ;Alternative donor (unrelated donor, haplotype donor) conditioning regimen: Busulfan (BU) 3.2 mg/kg/d (0.8 mg/kg, q6h) x 2D (-7 to -6d) + cyclophosphamide (CY) 50 mg/kg/d x 4D (-5 to -2D) + ATG 2.5 mg/kg per day x 4D (-5 to -2D). ;Treatment regimen for GVHD: Grade II treatment, methylprednisolone 1-2 mg/kg, divided into two doses, second-line drugs can be selected as appropriate: FK506, MMF, MTX, ATG, CD25 monoclonal antibody, etc.Hormone reduction as appropriate. ;Symptomatic and supportive treatment: Transplant-related complications such as infection, bleeding, hemorrhagic cystitis, epilepsy and mucositis, as well as immunoglobulin and nutritional support were routinely given to the participating units. | Hongci Hematology Branch of the First Affiliated Hospital of Soochow University; Hongci Hematology Branch of the First Affiliated Hospital of Soochow University, Self-funded | Classic PNH and PNH with bone marrow failure | | | | |
ChiCTR2200067000: A randomized controlled clinical study of hydroxychloroquine in the treatment of idiopathic membranous nephropathy |
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| Not yet recruiting | 4 | 146 | | Hydroxychloroquine (HCQ)+tacrolimus (FK506)+hormone (P) ;Placebo+tacrolimus (FK506)+hormone (P) | The Seventh Affiliated Hospital of Sun Yat sen University; The Seventh Affiliated Hospital of Sun Yat sen University, 735 Project of the Seventh Affiliated Hospital of Sun Yat sen University | idiopathic membranous nephropathy | | | | |