Tacrolimus (DrugBank: Tacrolimus)
32 diseases| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 1 |
| 6 | パーキンソン病 | 1 |
| 11 | 重症筋無力症 | 7 |
| 13 | 多発性硬化症／視神経脊髄炎 | 1 |
| 36 | 表皮水疱症 | 1 |
| 46 | 悪性関節リウマチ | 17 |
| 49 | 全身性エリテマトーデス | 4 |
| 50 | 皮膚筋炎／多発性筋炎 | 8 |
| 51 | 全身性強皮症 | 3 |
| 53 | シェーグレン症候群 | 4 |
| 60 | 再生不良性貧血 | 14 |
| 61 | 自己免疫性溶血性貧血 | 1 |
| 62 | 発作性夜間ヘモグロビン尿症 | 1 |
| 65 | 原発性免疫不全症候群 | 5 |
| 66 | IgA腎症 | 2 |
| 85 | 特発性間質性肺炎 | 1 |
| 95 | 自己免疫性肝炎 | 2 |
| 96 | クローン病 | 4 |
| 97 | 潰瘍性大腸炎 | 17 |
| 113 | 筋ジストロフィー | 1 |
| 151 | ラスムッセン脳炎 | 1 |
| 158 | 結節性硬化症 | 1 |
| 164 | 眼皮膚白皮症 | 1 |
| 222 | 一次性ネフローゼ症候群 | 26 |
| 224 | 紫斑病性腎炎 | 1 |
| 226 | 間質性膀胱炎（ハンナ型） | 1 |
| 227 | オスラー病 | 2 |
| 228 | 閉塞性細気管支炎 | 1 |
| 283 | 後天性赤芽球癆 | 2 |
| 284 | ダイアモンド・ブラックファン貧血 | 1 |
| 285 | ファンコニ貧血 | 1 |
| 299 | 嚢胞性線維症 | 2 |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01884571 (ClinicalTrials.gov) | October 2013 | 19/6/2013 | Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) | A Novel Immunosuppression Intervention for the Treatment of Amyotrophic Lateral Sclerosis (ALS) | Amyotrophic Lateral Sclerosis (ALS) | Drug: Basiliximab;Drug: Methylprednisolone;Drug: Prednisone;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Emory University | ALS Association | Completed | 18 Years | N/A | All | 31 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-JMA-IIA00385 | 01/08/2018 | 12/09/2018 | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Kyoto Trial to Evaluate the Safety and Efficacy of iPSC-derived dopaminergic progenitors in the treatment of Parkinson's Disease | Parkinson's disease | Intervention type:DRUG. Intervention1:TACROLIMUS TABLETS, Dose form:TABLET, Route of administration:ORAL, intended dose regimen:In the early phase, the immunosuppressant is orally administered 0.03 to 0.15 mg/kg, twice a day, and the targeted blood concentration is within a range of 5-10 ng/mL as a trough value.. | Kyoto University Hospital | NULL | Temporarily Closed | >=50 YEARS | <70 YEARS | BOTH | 7 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04182984 (ClinicalTrials.gov) | November 4, 2019 | 26/11/2019 | TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study | TheRapeutic Effect of Different immunosuppressAnts on Non-Thymoma Ocular Myasthenia Gravis: a Real-world Study | Ocular Myasthenia Gravis | Drug: Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil) | Tang-Du Hospital | NULL | Recruiting | 18 Years | 75 Years | All | 200 | China | |
| 2 | JPRN-UMIN000015019 | 2014/09/02 | 02/09/2014 | Initial therapy for myasthenia gravis of combined therapy for tacrolimus and IVIG | Myasthenia gravis | Tacrolimus and IVIG | Kansai medical university | NULL | Recruiting | Not applicable | Not applicable | Male and Female | 20 | Not applicable | Japan | |
| 3 | JPRN-UMIN000007671 | 2012/04/01 | 09/04/2012 | Randomized comparative study on efficacy and safety of reduced-dose steroid combined with tacrolimus vs conventional-dose steroid in late- or elderly-onset myasthenia gravis patients | Myasthenia gravis | Administration of prednisolone 35 mg/day with tacrolimus 3mg a day Administration of prednisolone 50 mg/day | Department of Neurology, Chiba University Graduate School of Medicine | NULL | Recruiting | 50years-old | Not applicable | Male and Female | 40 | Not applicable | Japan | |
| 4 | JPRN-UMIN000007679 | 2012/04/01 | 09/04/2012 | Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients | Myasthenia gravis | Administration of tacrolimus 3 mg/day Administration of prednisolone 5 mg/day anticholinesterases | Department of Neurology, Chiba University Graduate School of Medicine | NULL | Recruiting | 20years-old | Not applicable | Male and Female | 60 | Not selected | Japan | |
| 5 | NCT01325571 (ClinicalTrials.gov) | March 2011 | 16/3/2011 | A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia Gravis | A Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid Therapy | Myasthenia Gravis | Drug: Tacrolimus capsule;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma China, Inc. | Completed | 18 Years | 70 Years | Both | 83 | Phase 3 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT00309088 (ClinicalTrials.gov) | April 2006 | 29/3/2006 | FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) Patients | FK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis Patients | Myasthenia Gravis | Drug: tacrolimus;Drug: placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 80 | Phase 3 | Japan |
| 7 | NCT00309101 (ClinicalTrials.gov) | February 2006 | 29/3/2006 | An Open Study for Steroid Resistant, Non-Thymectomized MG Patients | FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients | Myasthenia Gravis | Drug: tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 11 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00298662 (ClinicalTrials.gov) | February 2003 | 2/3/2006 | Combination Therapy of Betaseron-Prograf in Multiple Sclerosis | A Pilot Safety and Tolerability Open-Label Study of Interferon Beta-1b in Combination With Tacrolimus in Patients Suffering From Multiple Sclerosis Who Have Failed Treatment With Approved Disease Modifying Agents | Multiple Sclerosis | Drug: Interferon beta-1b and Tacrolimus | Clinique de sclérose en plaques et neuromusculaire de l'Outaouais | NULL | Active, not recruiting | 18 Years | 55 Years | Both | 30 | Phase 2 | Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02582775 (ClinicalTrials.gov) | March 2016 | 16/10/2015 | MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs | MT2015-20: Biochemical Correction of Severe Epidermolysis Bullosa by Allogeneic Cell Transplantation and Serial Donor Mesenchymal Cell Infusions | Epidermolysis Bullosa | Drug: Thymoglobulin;Drug: Cyclophosphamide;Drug: Fludarabine;Radiation: Total Body Irradiation;Procedure: Bone marrow infusion;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Biological: Donor mesenchymal stem cell infusions;Drug: Busulfan | Masonic Cancer Center, University of Minnesota | NULL | Recruiting | N/A | 25 Years | All | 84 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03737708 (ClinicalTrials.gov) | February 13, 2019 | 8/11/2018 | A Study Comparing Biologics + Methotrexate With Biologics + Tacrolimus in Patients With Rheumatoid Arthritis (RA) | Compare Efficacy and Safety Between Biologics + Methotrexate (MTX) vs Biologics + Tacrolimus (TAC) (Switched From Biologics + Methotrexate (MTX)) in the Patients With Rheumatoid Arthritis (RA): Randomized, Interventional, Open, Active Controlled, Parallel Group, Multicenter-designed, Phase 4 Clinical Trial | Rheumatoid Arthritis (RA) | Drug: tacrolimus;Drug: methotrexate;Biological: adalimumab;Biological: tocilizumab;Biological: abatacept | Astellas Pharma Korea, Inc. | NULL | Completed | 19 Years | 75 Years | All | 22 | Phase 4 | Korea, Republic of |
| 2 | NCT02373202 (ClinicalTrials.gov) | February 2015 | 12/2/2015 | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) | A Randomized, Double-blind, Multicenter Study Evaluating the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Sarilumab;Drug: Sulfasalazine;Drug: Leflunomide;Drug: Bucillamine;Drug: Tacrolimus;Drug: Mizoribine | Sanofi | Regeneron Pharmaceuticals | Completed | 20 Years | N/A | All | 91 | Phase 3 | Japan |
| 3 | NCT02837978 (ClinicalTrials.gov) | January 2015 | 13/7/2016 | The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment | Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China | Arthritis, Rheumatoid | Drug: Tacrolimus;Drug: MTX | Qiang Shu | NULL | Recruiting | 18 Years | 80 Years | All | 150 | Phase 4 | China |
| 4 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | |
| 5 | JPRN-UMIN000012690 | 2013/12/28 | 27/12/2013 | Study of Actemura Remission induction of RAand Sequential Maintenance of Remission by Reasonable cost Treatment | Rheumatoid Arthritis | tocilizumab+tacrolimus+Bucillamine tocilizumab | National hospital organization Chiba east national hospital Clinical Research Center | NULL | Complete: follow-up complete | 20years-old | 99years-old | Male and Female | 60 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-UMIN000010126 | 2013/02/25 | 26/02/2013 | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease | Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in rheumatoid arthritis patients with interstitial lung disease - Efficacy and safety of treatment with moderate doses of corticosteroid and immunosuppressants in RA-ILD | Interstitial lung disease related to rheumatoid arthritis | In cases with UIP/NSIP pattern ILD, treatment is started with prednisolone and tacrolimus. For safety concern, the doses of tacrolimus should not exceed the dose approved in Japan and are adjusted to maintain blood trough levels less than 10 ng/ml. Prednisolone is started at the dose of 0.5 mg/kg/day and continued at the initial dose through 2-4 weeks, then reduced by 5 mg every 2-4 weeks. After the dose of prednisolone reaches 15 mg/day, it is reduced by 2.5 mg. After the dose of prednisolone reaches 10 mg, it is reduced by 1 mg every 4 weeks. The dose of prednisolone should be tapered to achieve 0.2 mg/kg/day at week 24. Prednisolone should be maintained at least 5 mg/day until month 12. Then prednisolone can be either continued, reduced or stopped later on. In cases with OP pattern ILD, prednisolone is started, tapered and maintained as mentioned in cases with UIP/NSIP pattern ILD. Methotrexate is started after the dose of prednisolone reaches 0.3 to 0.4 mg/kg/day. Methotrexate is increased to the maximal tolerable dose, but should not exceed 16 mg/week. Methotrexate should be used following the guideline published by Japan College of Rheumatology. If methotrexate is not feasible by any reason, it can be substituted by tacrolimus and tacrolimus should be used as mentioned in UIP/NSIP pattern ILD cases. | Department of Lifetime Clinical Immunology, Tokyo Medical and Dental University | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 34 | Not applicable | Japan |
| 7 | NCT01746680 (ClinicalTrials.gov) | August 2012 | 4/12/2012 | Efficacy and Safety Study of Tacrobell to Treat Rheumatoid Arthritis | Phase IV STudy of Tacrobell in Active Rheumatoid Arthritis | Rheumatoid Arthritis | Drug: Tacrolimus with Methotrexate | Chong Kun Dang Pharmaceutical | NULL | Completed | 20 Years | N/A | Both | 111 | Phase 4 | Korea, Republic of |
| 8 | NCT01870908 (ClinicalTrials.gov) | August 2012 | 4/6/2013 | Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients | Drug Use-result Survey to Assess the Safety and Efficacy of the Combination of Tacrolimus + Biological Agents in Daily Clinical Settings | Rheumatoid Arthritis | Drug: tacrolimus;Drug: biological agents | Astellas Pharma Inc | NULL | Completed | N/A | N/A | Both | 664 | N/A | Japan |
| 9 | JPRN-UMIN000008572 | 2012/07/31 | 31/07/2012 | The Kitasato institute Non-inferiorty trial of Etanercept and Tacrolimus ,the combined therapy with Methotrexate in rhumatoid arthritis patients | Rheumatoid arthritis (RA) with inadequate response to methotrexate (MTX) | Tacrolimus group patients receive daily the optimal dosage of tacrolimus within the range between 1.5-3.0 mg/day for 52 weeks. Etanercept group patient receive weekly subcutaneous injection of etanercept 50mg for 52 weeks. | Department of Rheumatology and infectious disease, Kitasato university school of medicine | 1)Kitasato institute medical center hospital2)Kitasato institute hospital3)Ishikawa internal medicine clinic | Recruiting | 20years-old | 70years-old | Male and Female | 80 | Not applicable | Japan | |
| 10 | JPRN-UMIN000007205 | 2012/02/01 | 02/02/2012 | The efficacy and safety of adding tacrolimus to methotrexate in elderly patients with rheumatoid arthritis | Rheumatoid arthritis | 1) Tacrolimus Oral administration of tacrolimus is started usually at a dose of 1.5 mg/day immediately after informed consent is obtained. The dose can be increased or decreased within the limits of 3 mg/day with taking into account symptoms, adverse reactions and so on. However, the administration of tacrolimus can be started at a dose of 0.5 or 1.0 mg/day in order to reduce adverse effects. | Juntendo University | NULL | Pending | 65years-old | Not applicable | Male and Female | 30 | Not selected | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | JPRN-UMIN000006702 | 2012/02/01 | 11/11/2011 | A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis | rheumatoid arthritis | Intensive treatment group Period: 24 weeks In the intensive treatment group, a patient starts treatment with MTX at 8mg/week. Dosage is increased to 0.25mg/kg/week by week 8 and is further increased to his or her maximum tolerable dosage by week 12. The maximum tolerable dosage is maintained until week 24. If a patient shows inadequate response to MTX and does not achieve SDAI(simplified disease activity index)emission or CDAI (linical disease activity index)remission by week 16, additional treatment with tacrolimus, bucillamine, sarazosulfapyridine, or biologics will be started as scheduled in the protocol. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. Conventional treatment group Period: 24 weeks In the control group, a patient starts treatment with MTX, tacrolimus, bucillamine, sarazosulfapyridine, or biologics by attending rheumatologists' discretion by week 24. Biologics are allowed on and after week 12. After week 24, both groups receive treatments by attending rheumatologists'discretion and are followed until week 72. | Tokyo Medical and Dental University | Department of Pharmacovigilance | Complete: follow-up continuing | 20years-old | 70years-old | Male and Female | 290 | Not applicable | Japan | |
| 12 | NCT01511003 (ClinicalTrials.gov) | December 5, 2011 | 4/1/2012 | A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs) | An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 20 Years | 75 Years | All | 128 | Phase 4 | Korea, Republic of |
| 13 | NCT01224041 (ClinicalTrials.gov) | August 2009 | 18/10/2010 | Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate | Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 18 Years | 75 Years | Both | 78 | Phase 4 | Korea, Republic of |
| 14 | NCT01224418 (ClinicalTrials.gov) | May 2008 | 14/10/2010 | A Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate | Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study | Rheumatoid Arthritis | Drug: Tacrolimus | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 18 Years | 75 Years | Both | 50 | Phase 4 | Korea, Republic of |
| 15 | JPRN-UMIN000000512 | 2006/10/01 | 03/11/2006 | Efficacy of tacrolimus in rheumatoid arthritis patients who have been treated unsuccessfully with infliximab and methotrexate | Rheumatoid Arthritis | If the score of DAS28 is under 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, doses of methotrexate will reduced to 2mg/w. When the score of DAS28 increses, tacrolimus will be administered instead of methotrexate. Period of observation is 32 weeks. If the score of DAS28 is over 3.2 in rheumatoid arthritis patients who have received infliximab and methotrexate, tacrolimus will be administered. Period of observation is 32 weeks. | Rheumatosurgery, Osaka City University Medical School | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 30 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT00319917 (ClinicalTrials.gov) | April 2006 | 27/4/2006 | A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients | FK506 Phase 4 Study: A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients | Rheumatoid Arthritis | Drug: tacrolimus;Drug: placebo | Astellas Pharma Inc | NULL | Completed | 20 Years | 64 Years | Both | 123 | Phase 4 | Japan |
| 17 | NCT00036153 (ClinicalTrials.gov) | March 2002 | 8/5/2002 | Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis | A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate | Rheumatoid Arthritis | Drug: Tacrolimus (Prograf®);Drug: Methotrexate | Astellas Pharma Inc | Astellas Pharma US, Inc. | Completed | 18 Years | N/A | Both | 210 | Phase 3 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02080195 (ClinicalTrials.gov) | September 13, 2016 | 28/2/2014 | Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE) | A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE | Lupus Erythematosus;Graft-versus-host Disease | Drug: Cyclophosphamide;Drug: Fludarabine;Drug: Tacrolimus;Drug: Mycophenolate Mofetil;Drug: Rabbit antithymocyte globulin;Radiation: Total body irradiation;Biological: Allogeneic bone marrow transplant | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Maryland Stem Cell Research Fund | Terminated | 18 Years | 75 Years | All | 1 | Phase 1;Phase 2 | United States |
| 2 | JPRN-UMIN000025328 | 2015/12/05 | 25/12/2016 | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis | A Randomized Open-label Study to Evaluate the Efficacy and Safety of Tacrolimus and Corticosteroids in Comparison With Mycophenolate Mofetil and Corticosteroids in Subjects With Class III/IV+/-V Lupus Nephritis - Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis | systemic lupus erythematosus | Tacrolimus Mycophenolate Mofetil | The University of Hong Kong | NULL | Recruiting | 18years-old | 75years-old | Male and Female | 200 | Not selected | Japan,Asia(except Japan) |
| 3 | JPRN-UMIN000004182 | 2010/10/01 | 30/09/2010 | efficacy and safety of tacrolimus for mild/modelate flare in patients with systemic lupus erythematosus | systemic lupus erythematosus | Administration of Tacrolimus | Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 30 | Not applicable | Japan | |
| 4 | NCT00125307 (ClinicalTrials.gov) | January 2004 | 29/7/2005 | Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis | Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis | Lupus Nephritis;Lupus Erythematosus, Systemic | Drug: tacrolimus | Chinese University of Hong Kong | NULL | Completed | 18 Years | N/A | Both | 20 | Phase 4 | Hong Kong;China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900028143 | 2020-01-01 | 2019-12-13 | Effect of Tacrolimus on dermatomyositis/polymyositis | A Single-center, randomized, controlled trial for Tacrolimus in patients with dermatomyositis/polymyositis | dermatomyositis/polymyositis | Control group:glucocorticoid ;Treatment group:Glucocorticoid+Tacrolimus;Control group:Glucocorticoid+Cyclophosphamide; | Department of Rheumatology and Immunology, Tianjin Medical University General Hospital | NULL | Pending | 18 | 70 | Both | Control group:20;Treatment group:20;Control group:20; | Phase 4 | China |
| 2 | JPRN-UMIN000032193 | 2018/04/11 | 13/04/2018 | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial | Efficacy and safety of combination therapy of corticosteroid and tacrolimus for patients with anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis-associated interstitial lung disease: a prospective multicenter clinical trial - Combination therapy of corticosteroid and tacrolimus for anti-MDA5 antibody-positive DM-ILD | anti-melanoma differentiation antigen 5 antibody-positive dermatomyositis (DM)/clinically amyopathic dermatomyositis (CADM)-associated interstitial lung disease | Patients without poor prognostic factors: combination therapy of corticosteroid (prednisolone) and tacrolimus for 12 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day (Maximum dose of prednisolone is 60mg/body/day). Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more in the study period (12 months). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. For patients with poor prognostic factors, attending physician can chose any treatments (e.g. corticosteroid, immunosuppressant, IVIG). The patients were followed up for 12 months. | Second Division, Department of Internal Medicine, Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 40 | Not selected | Japan |
| 3 | JPRN-UMIN000032022 | 2018/04/01 | 01/04/2018 | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial | Efficacy and safety of corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for patients with anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis-associated interstitial lung disease: a prospective randomized multicenter clinical trial - Corticosteroid monotherapy versus combination therapy of corticosteroid and tacrolimus for anti-ARS antibody-positive PM/DM-ILD | anti-aminoacyl-tRNA synthetase antibody-positive polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated interstitial lung disease | Arm 1: corticosteroid (prednisolone) monotherapy for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Arm 2: combination therapy of corticosteroid (prednisolone) and tacrolimus for 24 months Initial dose of oral prednisolone is 0.7 - 1mg/kg/day. (Maximum dose of prednisolone is 60mg/body/day.) Intravenous methylprednisolone pulse therapy (0.5 - 1g/day for 3 days) is permitted according to the initial disease activity. After 4 weeks of initial treatment, prednisolone is tapered by approximately 10 to 20% every 2 to 4 weeks (from 1 to 9 month) and continued at dose of 0.125 - 0.15 mg/kg/day or more (from 9 to 12 month) or 0.1 - 0.125 mg/kg/day or more (from 12 to 24 month). Tacrolimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. | Hamamatsu University School of Medicine | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 66 | Not selected | Japan |
| 4 | JPRN-UMIN000015469 | 2014/10/20 | 18/10/2014 | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease | Comparison of efficacy between tacrolimus and cyclosporine for the treatment of polymyositis/dermatomyositis-associated interstitial lung disease - Comparison between tacrolimus and cyclosporine for the treatment of PM/DM-ILD | polymyositis/dermatomyositis/clinically amyopathic dermatomyositis-associated Interstitial lung disease | arm1: tacrolimus and predonisolon therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Taclorimus is administered orally at initial dose of 0.075 mg/kg/day (twice daily) and adjusted over time to maintain a whole-blood trough level of 5 - 10 ng/ml. arm2: cyclosporine and predonisolone therapy for 52 weeks Initial dose of oral prednisolone is 0.6 - 1 mg/kg/day. Intravenous methylprednisolone pulse therapy (1 g/day for 3 days) is permitted according to the disease activity. After 4 weeks of initial treatment, prednisolone was tapered by approximately 10 to 20% every 2 to 4 weeks and continued at dose of 0.125 mg/kg/day or more. Cyclosporine is administered orally at initial dose of 3 mg/kg/day (twice daily before meal) and adjusted over time to maintain a whole-blood trough level of 100 - 150 ng/ml. | Second Division, Department of Internal medicine, Hamamatsu University School of Medicine | NULL | Complete: follow-up complete | 18years-old | 75years-old | Male and Female | 50 | Not selected | Japan |
| 5 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02159651 (ClinicalTrials.gov) | April 1, 2014 | 6/6/2014 | A Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia | Specified Drug Use-results Survey for Long-term Use of Prograf Capsules in Patient With Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Interstitial Pneumonia Associated With Polymyositis/Dermatomyositis | Drug: tacrolimus | Astellas Pharma Inc | NULL | Completed | N/A | N/A | All | 179 | Japan | |
| 7 | JPRN-JMA-IIA00012 | 20/07/2007 | 05/07/2007 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An open-label clinical trial of the combination treatment of tacrolimus and corticosteroid in polymyositis/dermatomyositis patients with interstitial pneumonitis, with comparison against corticosteroid-treated historical controls | Interstitial pneumonitis associated with polymyositis/dermatomyositis | Intervention type:DRUG. Intervention1:Tacrolimus, Dose form:CAPSULE, Route of administration:ORAL, intended dose regimen:Start at the standard starting dose of 0.075mg/kg/day divided into two doses, then adjust doses based on clinical response and tolerability, but maintain whole blood trough levels between 5 to 10 ng/mL and total daily doses equal to or below 0.3mg/kg.. | IMPPACT study central office | Hokkaido University Hospital, Tsukuba University Hospital, Chiba University Hospital, The University of Tokyo Hospital, Tokyo Medical and Dental University Hospital, International Medical Center of Japan, Juntendo University Hospital, Keio University Hospital, Osaka Minami Medical Center, Tokushima University Hospital, Nagasaki University Hospital of Medicine and Dentistry | Completed | >=16 YEARS | <75 YEARS | BOTH | 20 | Japan | |
| 8 | NCT00504348 (ClinicalTrials.gov) | July 2007 | 19/7/2007 | Investigation in Myositis-associated Pneumonitis of Prednisolone And Concomitant Tacrolimus | An Open-label Clinical Trial of the Combination Treatment of Tacrolimus and Corticosteroid in Polymyositis/Dermatomyositis Patients With Interstitial Pneumonitis, With Comparison Against Corticosteroid-treated Historical Controls | Interstitial Pneumonitis;Polymyositis;Dermatomyositis | Drug: Tacrolimus | Tokyo Medical and Dental University | Japan Medical Association;Astellas Pharma Inc | Completed | 16 Years | 74 Years | All | 25 | Phase 2;Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02680717 (ClinicalTrials.gov) | March 2016 | 9/2/2016 | Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea | Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea | Scleroderma | Drug: Clobetasol;Drug: Calcipotriene;Drug: Tacrolimus | Medical College of Wisconsin | Mayo Clinic;Seattle Children's Hospital;University of Toronto | Withdrawn | 2 Years | 18 Years | All | 0 | Phase 1 | NULL |
| 2 | NCT01047072 (ClinicalTrials.gov) | January 2010 | 11/1/2010 | Low-Dose Conditioning Followed by Donor Stem Cell Transplant in Treating Patients With Severe Systemic Sclerosis | Phase II Clinical Trial of Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma | Drug: fludarabine phosphate;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Biological: rituximab;Drug: cyclophosphamide;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | National Cancer Institute (NCI) | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 2 | United States |
| 3 | NCT00622895 (ClinicalTrials.gov) | September 1, 2006 | 22/2/2008 | Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis | Allogeneic Hematopoietic Cell Transplantation After Nonmyeloablative Conditioning for Patients With Severe Systemic Sclerosis | Systemic Scleroderma;Severe Systemic Sclerosis | Drug: fludarabine phosphate;Drug: Mycophenolic Acid;Drug: tacrolimus;Radiation: total-body irradiation;Procedure: bone marrow transplantation;Procedure: reduced intensity allogeneic hematopoietic stem cell transplantation;Procedure: quality-of-life assessment;Other: laboratory biomarker analysis;Other: flow cytometry;Procedure: biopsy | Fred Hutchinson Cancer Research Center | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | N/A | 70 Years | All | 3 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03865888 (ClinicalTrials.gov) | October 30, 2018 | 16/12/2018 | Comparing Effect of Topical Tacrolimus 0.03% Versus Cyclosporine 0.05% in Dry Eyes of Secondary Sjogren Syndrome | Evaluation of the Effect of Topical Application of Tacrolimus 0.03% (FK506) Eye Drops Versus Cyclosporine 0.05% Eye Drops in Treatment of Dry Eye in Secondary Sjogren Syndrome | Dry Eye;Sjogren Syndrome | Drug: Cyclosporins;Drug: Tacrolimus | Pavly Moawd | NULL | Completed | 20 Years | 70 Years | All | 60 | Phase 3 | Egypt |
| 2 | ChiCTR-IPR-17013772 | 2018-01-01 | 2017-12-08 | A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye | A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye | Sjogren's Syndrome Dry Eye | group of tacrolimus eye drops:tacrolimus eye drops;group of flurometholone eye drops:flurometholone eye drops; | The Eye Hospital of Wenzhou Medical University | NULL | Pending | Both | group of tacrolimus eye drops:30;group of flurometholone eye drops:30; | China | |||
| 3 | ChiCTR-OIB-16007789 | 2016-01-18 | 2015-12-30 | 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation | 0.1%Tacrolimus (FK506) in the treatment of sjogren's syndrome clinical efficacy evaluation | Sjogren's syndrome | Tacrolimus therapy group:0.1% FK506 + 0.1% sodium hyaluronate eye drops Twice a day for 30 days; | Eye Institute of Xiamen University | NULL | Recruiting | 18 | 70 | Both | Tacrolimus therapy group:30; | 4 (Phase 4 study) | China |
| 4 | NCT01850979 (ClinicalTrials.gov) | February 2010 | 1/5/2013 | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops | Treatment of Dry Eye Using 0.03% Tacrolimus Eye Drops: Prospective Double-Blind Randomized Study | Sjogren Syndrome;Dry Eye Syndrome | Drug: Tacrolimus;Drug: Olive Oil | University of Sao Paulo General Hospital | NULL | Completed | 40 Years | 60 Years | Both | 24 | Phase 4 | Brazil |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04403321 (ClinicalTrials.gov) | July 1, 2020 | 21/5/2020 | Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia Patients | Efficacy and Safety of Eltrombopag + Tacrolimus/Cyclosporin A in Chinese Refractory or Relapsed Aplastic Anemia Patients | Aplastic Anemia;Drug Effect | Drug: Tacrolimus;Drug: Placebo (for Tacrolimus);Drug: Cyclosporin A | Peking Union Medical College Hospital | NULL | Not yet recruiting | 16 Years | 80 Years | All | 60 | Phase 2 | China |
| 2 | NCT02918292 (ClinicalTrials.gov) | July 3, 2017 | 27/9/2016 | Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502) | Optimizing Haploidentical Aplastic Anemia Transplantation (CHAMP) (BMT CTN #1502) | Severe Aplastic Anemia | Drug: Antithymocyte Globulin (ATG);Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total Body Irradiation (TBI);Procedure: Haplo HSCT;Drug: Tacrolimus;Drug: Mycophenolate mofetil (MMF);Drug: G-CSF | Medical College of Wisconsin | National Heart, Lung, and Blood Institute (NHLBI);National Cancer Institute (NCI);Blood and Marrow Transplant Clinical Trials Network;National Marrow Donor Program | Recruiting | N/A | 75 Years | All | 30 | Phase 2 | United States |
| 3 | NCT02960646 (ClinicalTrials.gov) | January 18, 2017 | 8/11/2016 | Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies | Phase I Clinical Trial Using an Engineered Peripheral Blood Graft for Haploidentical Transplantation | Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia;Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome;Aplastic Anemia;Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive;Lymphoblastic Lymphoma;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma;Recurrent Hodgkin Lymphoma;Recurrent Non-Hodgkin Lymphoma;Recurrent Plasma Cell Myeloma;Therapy-Related Myelodysplastic Syndrome | Drug: Cyclophosphamide;Biological: Filgrastim;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Melphalan;Procedure: Peripheral Blood Stem Cell Transplantation;Biological: Rituximab;Drug: Tacrolimus;Radiation: Total-Body Irradiation | M.D. Anderson Cancer Center | National Cancer Institute (NCI) | Recruiting | 18 Years | 65 Years | All | 12 | Phase 1 | United States |
| 4 | NCT02833805 (ClinicalTrials.gov) | September 2016 | 12/7/2016 | NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia | A Phase II Trial of Non-Myeloablative (NMA) Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Donor (MUD) Bone Marrow for Newly Diagnosed Patients With Severe Aplastic Anemia | Severe Aplastic Anemia;Aplastic Anemia;Bone Marrow Failure;Immunosuppression | Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: Total body irradiation;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | NULL | Active, not recruiting | N/A | N/A | All | 21 | Phase 2 | United States |
| 5 | NCT02566304 (ClinicalTrials.gov) | November 13, 2015 | 30/9/2015 | Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies | A Two Step Approach to Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies | Acute Myeloid Leukemia;Acute Myeloid Leukemia in Remission;Aplastic Anemia;Chronic Myelomonocytic Leukemia;Hodgkin Lymphoma;Indolent Non-Hodgkin Lymphoma;Malignant Neoplasm;Myelodysplastic Syndrome;Myeloproliferative Neoplasm;Plasma Cell Myeloma;Refractory Anemia;Refractory Anemia With Excess Blasts;Refractory Anemia With Ring Sideroblasts;Refractory Cytopenia With Multilineage Dysplasia;Refractory Cytopenia With Multilineage Dysplasia and Ring Sideroblasts | Drug: Fludarabine;Radiation: Total-Body Irradiation;Biological: T Cell-Depleted Donor Lymphocyte Infusion;Drug: Cyclophosphamide;Procedure: Peripheral Blood Stem Cell Transplantation;Procedure: Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Tacrolimus;Drug: Mycophenolate mofetil | Sidney Kimmel Cancer Center at Thomas Jefferson University | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | NCT02224872 (ClinicalTrials.gov) | August 2014 | 18/8/2014 | Transplantation of Partially Mismatched Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia | A Phase II Trial of Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched/Haploidentical Related or Matched Unrelated Bone Marrow for Patients With Refractory Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes | Severe Aplastic Anemia;Bone Marrow Failure Syndromes | Procedure: Bone marrow transplant;Drug: Thymoglobulin;Drug: Fludarabine;Drug: Cyclophosphamide;Radiation: TBI;Drug: Mesna;Drug: Tacrolimus;Drug: Mycophenolic acid mofetil | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | NULL | Active, not recruiting | N/A | 73 Years | All | 18 | Phase 2 | United States |
| 7 | NCT01529827 (ClinicalTrials.gov) | February 28, 2012 | 6/2/2012 | Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation | Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome | Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Roswell Park Cancer Institute | NULL | Completed | 3 Years | 75 Years | All | 94 | Phase 2 | United States |
| 8 | NCT01384513 (ClinicalTrials.gov) | August 4, 2011 | 27/6/2011 | A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies | A Two Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies | Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Aplastic Anemia;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Myelodysplastic Syndromes;Chronic Eosinophilic Leukemia;Chronic Myelomonocytic Leukemia;Chronic Neutrophilic Leukemia;Essential Thrombocythemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Juvenile Myelomonocytic Leukemia;Mastocytosis;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Polycythemia Vera;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Anemia;Refractory Anemia With Ringed Sideroblasts;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Myelodysplastic Syndromes;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenström Macroglobulinemia | Drug: Fludarabine;Drug: Busulfan;Radiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide (CY);Drug: Tacrolimus;Drug: Mycophenolate mofetil;Device: Allogeneic hematopoietic stem cell transplantation;Procedure: Peripheral blood stem cell transplantation (PBSCT) | Sidney Kimmel Cancer Center at Thomas Jefferson University | NULL | Active, not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 9 | NCT01350245 (ClinicalTrials.gov) | July 2010 | 4/5/2011 | Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor | A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies in Remission From HLA Partially-Matched Related Donors | Acute Myeloid Leukemia;Myelodysplastic Syndromes;Biphenotypic Leukemia;Acute Lymphocytic Leukemia;Chronic Myeloid Leukemia;Chronic Lymphocytic Leukemia;Plasma Cell Neoplasms;Lymphoma;Hodgkin's Disease;Aplastic Anemia | Radiation: Total Body Irradiation (TBI);Biological: Donor Lymphocyte Infusion (DLI);Drug: Cyclophosphamide;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus;Device: Hematopoietic stem cell transplantation (HSCT) | Sidney Kimmel Cancer Center at Thomas Jefferson University | NULL | Completed | 18 Years | N/A | All | 28 | Phase 2 | United States |
| 10 | EUCTR2006-006577-25-SE (EUCTR) | 25/07/2007 | 11/06/2007 | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | A prospective randomized study comparing rapamune and tacrolimus vs. cyclosporine and methotrexate as immune prophylaxis in allogeneic hematopoietic stem cell transplantation, using HLA-A, -B, -DRB1 identical related or unrelated donors. A Nordic multicenter study. - Rapa + FK in stem cell transplantation | Graft versus host disease prophylaxis in patients receiving stem cell transplantation due to: chronic myeloid leukemia (CML) in 1st or 2nd chronic phase, acute myeloid leukemia (AML) in complete remission, acute lymphoblastic leukemia (ALL) in complete remission, myelodysplastic syndrome, chronic lymphocytic leukemia, lymphoma, non-malignant disorders, severe aplastic anemia, hemoglobinopathies and metabolic disorders MedDRA version: 9.1;Level: LLT;Classification code 10018799;Term: GVHD | Trade Name: Rapamune Product Name: Rapamune INN or Proposed INN: SIROLIMUS Other descriptive name: Rapamycin Trade Name: Prograf Product Name: Prograf INN or Proposed INN: TACROLIMUS Other descriptive name: FK-506 Trade Name: Sandimmun Neoral Product Name: Sandimmun Neoral INN or Proposed INN: CICLOSPORIN Other descriptive name: CsA Trade Name: Methotrexate Product Name: Methotrexate INN or Proposed INN: METHOTREXATE Other descriptive name: MTX | Karolinska Institutet | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Finland;Sweden | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT00358657 (ClinicalTrials.gov) | May 24, 2006 | 28/7/2006 | Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited Disorders | HLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting Cyclophosphamide | Immunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;Donor | Procedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body Irradiation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | N/A | 55 Years | All | 14 | Phase 2 | United States |
| 12 | NCT00295997 (ClinicalTrials.gov) | May 2005 | 23/2/2006 | Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia | Non-myeloablative Allogeneic Stem Cell Transplantation With Match Unrelated Donors for Treatment of Hematologic Malignancies and Renal Cell Carcinoma and Aplastic Anemia | Chronic Myeloproliferative Disorders;Kidney Cancer;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Neoplasms | Biological: anti-thymocyte globulin;Biological: filgrastim;Biological: graft-versus-tumor induction therapy;Biological: therapeutic allogeneic lymphocytes;Drug: busulfan;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methotrexate;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | University of California, San Francisco | National Cancer Institute (NCI) | Active, not recruiting | N/A | 74 Years | Both | 35 | N/A | United States |
| 13 | NCT00516152 (ClinicalTrials.gov) | November 2002 | 13/8/2007 | Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT | Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation | Chronic Myeloid Leukemia;Acute Myelogenous Leukemia;Myelodysplasia;Acute Lymphocytic Leukemia;Severe Aplastic Anemia;Non-Hodgkin's Lymphoma;Lymphoproliferative Disease;Multiple Myeloma;Advanced Myeloproliferative Disease | Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF | University of California, San Francisco | NULL | Completed | 15 Years | 61 Years | Both | 36 | Phase 2 | United States |
| 14 | NCT00053989 (ClinicalTrials.gov) | January 29, 2002 | 5/2/2003 | NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders | Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic Anemia | Biological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantation | Roswell Park Cancer Institute | NULL | Completed | 4 Years | 75 Years | All | 41 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03918265 (ClinicalTrials.gov) | May 4, 2019 | 16/4/2019 | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Autoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans Syndrome | Drug: Tacrolimus | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 80 | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01529827 (ClinicalTrials.gov) | February 28, 2012 | 6/2/2012 | Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation | Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome | Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Roswell Park Cancer Institute | NULL | Completed | 3 Years | 75 Years | All | 94 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04339777 (ClinicalTrials.gov) | September 22, 2020 | 8/4/2020 | Allogeneic Hematopoietic Stem Cell Transplant for People With Primary Immunodeficiency Diseases | A Phase II Study of Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immunodeficiency Diseases | Lymphoproliferative Disorders;Autoimmune Lymphoproliferative;Immune System Diseases;Common Variable Immunodeficiency;Primary T-cell Immunodeficiency Disorders | Drug: Busulfan test dose;Drug: Fludarabine;Drug: Busulfan;Drug: Alemtuzumab;Radiation: Total body Irradiation;Procedure: Allogeneic HSCT;Drug: Tacrolimus (Tacro);Drug: Mycophenolate mofetil (MMF);Drug: Cyclophosphamide (Cytoxan) | National Cancer Institute (NCI) | NULL | Recruiting | 4 Years | 69 Years | All | 56 | Phase 2 | United States |
| 2 | NCT01529827 (ClinicalTrials.gov) | February 28, 2012 | 6/2/2012 | Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation | Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome | Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Roswell Park Cancer Institute | NULL | Completed | 3 Years | 75 Years | All | 94 | Phase 2 | United States |
| 3 | NCT01220531 (ClinicalTrials.gov) | September 2010 | 22/9/2010 | Thymus Transplantation Safety-Efficacy | Safety and Efficacy of Thymus Transplantation in Complete DiGeorge Anomaly, IND#9836 | Complete DiGeorge Anomaly;DiGeorge Syndrome;DiGeorge Anomaly;Complete DiGeorge Syndrome | Biological: Thymus Tissue for Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Basiliximab;Drug: Mycophenolate mofetil | M. Louise Markert | National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD);Enzyvant Therapeutics GmbH | Available | N/A | N/A | All | United States | ||
| 4 | NCT00358657 (ClinicalTrials.gov) | May 24, 2006 | 28/7/2006 | Fludarabine Phosphate, Cyclophosphamide, and Total-Body Irradiation Followed by Donor Bone Marrow Transplant and Cyclophosphamide, Mycophenolate Mofetil, Tacrolimus, and Sirolimus in Treating Patients With Primary Immunodeficiency Disorders or Noncancerous Inherited Disorders | HLA-Haploidentical Related Marrow Grafts for the Treatment of Primary Immunodeficiencies and Other Nonmalignant Disorders Using Conditioning With Low-Dose Cyclophosphamide, TBI and Fludarabine and Postgrafting Cyclophosphamide | Immunodeficiency Syndrome;Non-Cancer Diagnosis;Severe Aplastic Anemia;Donor | Procedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Procedure: Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation;Drug: Sirolimus;Drug: Tacrolimus;Radiation: Total-Body Irradiation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI);National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | N/A | 55 Years | All | 14 | Phase 2 | United States |
| 5 | NCT00579527 (ClinicalTrials.gov) | December 19, 2005 | 20/12/2007 | Phase I/II Thymus Transplantation With Immunosuppression #950 | Phase I/II Trial of Thymus Transplantation With Immunosuppression, #950 | DiGeorge Anomaly;Complete DiGeorge Anomaly;Complete Atypical DiGeorge Anomaly;Complete DiGeorge Syndrome;Complete Atypical DiGeorge Syndrome | Biological: Cultured Thymus Tissue for Implantation (CTTI);Other: Cultured Thymus Tissue Implantation and Parental Parathyroid Transplantation;Procedure: Blood Draw;Drug: Rabbit anti-thymocyte globulin;Drug: Cyclosporine;Drug: Tacrolimus;Drug: Methylprednisolone or Prednisolone;Drug: Daclizumab;Drug: Mycophenolate mofetil | M. Louise Markert | National Institutes of Health (NIH);National Institute of Allergy and Infectious Diseases (NIAID);Enzyvant Therapeutics GmbH;Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | N/A | N/A | All | 14 | Phase 1;Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR-IPR-15006760 | 2015-08-07 | 2015-07-16 | Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study | Efficacy and Safety of Tacrolimus in the Treatment of Immunogloglumin A Nephropathy: a Glucocorticoids-controlled, multicenter, randomized, open label clinical study | IgA nephropathy | Tacrolimus Group :Tacrolimus;Glucocorticoids Group :Glucocorticoids; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Pending | 18 | 65 | Both | Tacrolimus Group :90;Glucocorticoids Group :90; | China | |
| 2 | NCT01224028 (ClinicalTrials.gov) | November 2010 | 18/10/2010 | A Study to Evaluate the Efficacy and Safety of Tacrolimus in Korean Nephropathy Patients | Double-blind, Randomized Placebo-controlled Clinical Trial for the Efficacy and Safety of a Calcineurin Inhibitor, Tacrolimus(Prograf Cap®) in Patients With Non-nephrotic Albuminuric, Normotensive IgA Nephropathy | IgA Nephropathy | Drug: Tacrolimus;Drug: Placebo | Astellas Pharma Inc | Astellas Pharma Korea, Inc. | Completed | 18 Years | 70 Years | Both | 40 | Phase 2 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ChiCTR1900027121 | 2019-10-28 | 2019-11-01 | The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial | The efficacy and safety of immunosuppressant in the treatment of nonspecific interstitial pneumonia (NSIP): a prospective, single-center, open, parallel-controlled trial | nonspecific interstitial pneumonia (NSIP) | Group-1:Mycophenolate mofetil dispersible tablets 2 g /d; Steroid 0.75 mg/kg/d;Group-2:Tacrolimus capsule, 3mg/d, Steroid 0.75 mg/kg/d;Group-3:Cyclophosphamide 1-2mg/kg/d, Steroid 0.75 mg/kg/d;Control group:Steroid from 0.75 mg/kg/d to 15 mg/d.; | Peking Union Medical College Hospital | NULL | Recruiting | 18 | 75 | Both | Group-1:30;Group-2:30;Group-3:30;Control group:30; | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000030743 | 2019/03/31 | 15/01/2018 | Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study | Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis Pilot Study - Efficacy and Safety of Tacrolimus as Secondline Therapy for Patients With Autoimmune Hepatitis | Autoimmune Hepatitis | Tacrolimus | Hiroshima University Hospital | NULL | Recruiting | 20years-old | 80years-old | Male and Female | 5 | Not selected | Japan |
| 2 | NCT00608894 (ClinicalTrials.gov) | December 2007 | 23/1/2008 | LCP-Tacro vs. Azathioprine for the Treatment of Autoimmune Hepatitis | A Phase II, Open-Label, Multi-Center, Prospective, Randomized Study of LCP-Tacro Tablets vs. Azathioprine, in Combination With Corticosteroids, for the Treatment of Autoimmune Hepatitis | Autoimmune Hepatitis | Drug: LCP-Tacro (tacrolimus);Drug: Azathioprine | Veloxis Pharmaceuticals | NULL | Terminated | 18 Years | N/A | All | 13 | Phase 2 | United States;Canada |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04154735 (ClinicalTrials.gov) | November 2019 | 8/3/2019 | Autologous Transplant Targeted Against Crohn's | Autologous Hematopoietic Stem Cell Transplant for Crohn's Disease | Crohn's Disease | Drug: Fludarabine;Drug: Cyclophosphamide;Drug: Mesna;Drug: Alemtuzumab;Drug: G-CSF;Drug: Rifaximin;Drug: Tacrolimus | Northwestern University | NULL | Withdrawn | 18 Years | 49 Years | All | 0 | Phase 2 | United States |
| 2 | NCT01570348 (ClinicalTrials.gov) | July 17, 2012 | 2/4/2012 | Crohn's Allogeneic Transplant Study | Allogeneic Hematopoietic Cell Transplantation for Patients With Treatment-Refractory Crohn's Disease: A Phase 2 Study | Crohn Disease | Procedure: Allogeneic Bone Marrow Transplantation;Drug: Cyclophosphamide;Drug: Fludarabine Phosphate;Other: Laboratory Biomarker Analysis;Drug: Mycophenolate Mofetil;Drug: Mycophenolic Acid;Other: Quality-of-Life Assessment;Drug: Tacrolimus;Radiation: Total-Body Irradiation | Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI);National Institutes of Health (NIH) | Terminated | 18 Years | 60 Years | All | 2 | Phase 2 | United States |
| 3 | NCT01233570 (ClinicalTrials.gov) | September 2010 | 2/11/2010 | Topical Tacrolimus 0.1% Ointment For Treatment Of Cutaneous Crohn's Disease | Topical Tacrolimus 0.1% Ointment for Treatment of Cutaneous Crohn's Disease | Crohn Disease | Drug: Tacrolimus | University of Aberdeen | NULL | Completed | 12 Years | N/A | Both | 20 | Phase 2 | United Kingdom |
| 4 | JPRN-UMIN000002796 | 2009/11/01 | 25/11/2009 | Effect of tacrolimus for patients with refractory Crohn's disease: A randomized, placebo-controlled trial. | Crohn's disease | We randomly assigned patients into either placebo or tacrolimus group at a ratio of 1:1 by use of stratified block randomization. Patients assigned to tacrolimus received for four weeks. For induction of remission, the dose of tacrolimus is increased with aiming at high trough level (10~15ng/ml). placebo control | Department of Gastroenterology and Hepatology, Kyoto University | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 50 | Phase 2 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000030988 | 2018/02/01 | 01/02/2018 | Open-label, randomized, two-parallel-arm, single center study to designed to evaluate azathioprine versus adalimumab after induction of tacrolimus in refractory ulcerative colitis therapy | Ulcerative Colitis | Induce azathioprine and continue maintenance therapy by azathioprine Induce adalimumab and continue maintenance therapy by adalimumab | Sakura Medical Center, Toho university | NULL | Pending | 15years-old | Not applicable | Male and Female | 53 | Not applicable | Japan | |
| 2 | NCT02954159 (ClinicalTrials.gov) | May 18, 2017 | 14/10/2016 | Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in UC | Induction of Response and Remission of Vedolizumab Monotherapy Vs Combination Therapy With Tacrolimus in Patients With Moderately to Severely Active Ulcerative Colitis | Ulcerative Colitis | Drug: Tacrolimus;Drug: Vedolizumab;Other: Placebo | Medical College of Wisconsin | Takeda | Terminated | 18 Years | 65 Years | All | 4 | Phase 3 | United States |
| 3 | JPRN-UMIN000024936 | 2016/11/30 | 22/11/2016 | Efficacy of additional Calcineurin inhibitors in anti TNF-alfa antibody refractory Ulcerative colitis | Ulcerative colitis | patients who received Infliximab continued to treat every 8 week and who received Adalimumab continued to treat every 2 week. Patients received Tacrolimus 0.5mg2Cap par day at day0. Day0 is day of first anti TNF-alfa antibody treat after participate this study. We control Tacrolimus trough levels 3 to 5 mg/ml. | Keio University Gastroenterology and Hepatology | NULL | Recruiting | 16years-old | 150years-old | Male and Female | 30 | Not selected | Japan | |
| 4 | JPRN-UMIN000015912 | 2014/12/15 | 15/12/2014 | Efficacy of maintenance therapy with adalimumab in ulcerative colitis achieving remission with tacrolimus | ulcerative colitis | Tacrolimus will be decreased gradually three months after it was administered. Adalimumab will be administrated three months after tacrolimus was administered, and tacrolimus will be decreased gradually. | Osaka Medical College | NULL | Recruiting | 16years-old | 70years-old | Male and Female | 50 | Not applicable | Japan | |
| 5 | JPRN-UMIN000013546 | 2014/06/01 | 31/03/2014 | The effect ofgrepefruit juice on the patients with autoimmune diseases taking tacrolimus | rheumatoid arthritis, lupus nephritis, polymyositis/dermatomyositis with interstitial pneumonia, ulcerative colitis | take a glass of grapefruit juice every day do not take grapefruit juice | Department of Rheumatology and Clinical Immunology, Kyoto University Hospital | NULL | Pending | 16years-old | 80years-old | Male and Female | 20 | Not applicable | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | JPRN-UMIN000013694 | 2014/05/13 | 11/04/2014 | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | Individualized tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs - Tacrolimus therapy for ulcerative colitis based on CYP3A5 SNPs | ulcerative colitis | determine CYP3A5 SNP status increase the initial dosage of tacrolimus | Kitasato University Kitasato Institute Hospital | NULL | Complete: follow-up complete | 18years-old | Not applicable | Male and Female | 30 | Not selected | Japan |
| 7 | JPRN-UMIN000013716 | 2014/04/15 | 15/04/2014 | A study of infliximab administration method for tacrolimus-resistant active ulcerative colitis | ulcerative colitis | After administrating tacrolimus and infliximab for 6 weeks,tacrolimus is tapered to 0mg. Infliximab monotherapy | Yokohama City University Medical Center | NULL | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 40 | Phase 2 | Japan | |
| 8 | JPRN-UMIN000004201 | 2013/12/02 | 14/09/2010 | The evaluation of efficacy for remission maintenance with immunomodulator following remission induction with tacrolimus in patients with moderate to severe active refractory ulcerative colitis.:mucosal healing for prognosis | The patients with moderate to severe active refractory ulcerative colitis | Group of remission maintenance therapy for 48 weeks with immunomodulator at from 2 to 4 weeks following remission induction with tacrolimus, Group of no remission maintenance therapy with immunomodulator following remission induction with tacrolimus, | Osaka City University, Graduate School of Medicine,Department of Gastroenterology | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 50 | Not selected | Japan | |
| 9 | JPRN-UMIN000010776 | 2013/06/01 | 01/06/2013 | An open label randomized controlled trial of tacrolimus versus cyclosporine treatment for severe ulcerative colitis | Ulcerative colitis | tacrolimus (Prograf) cyclosporine (Sandimmune) | Chiba University Hospital | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 40 | Not selected | Japan | |
| 10 | JPRN-UMIN000010612 | 2013/05/01 | 01/05/2013 | A comparative study of the efficacy of tacrolimus with infliximab in intractable ulcerative colitis | Ulcerative colitis | Tacrolimus will be administered orally for 10 weeks at the trough level of 10-15 ng/ml for the first 2 weeks following that of 5-10 ng/ml for the rest of the study period. Infliximab will be administered intravenously at the dose of 5 mg/kg at 0, 2, 6 weeks. | Department of Internal Medicine, Division of Gastroenterology and Hepatology, Keio University School of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 130 | Phase 4 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT01418131 (ClinicalTrials.gov) | October 2012 | 15/8/2011 | Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | A Multi-centre Double Blind Randomised Placebo-controlled Study of the Use of Rectal Tacrolimus in the Treatment of Resistant Ulcerative Proctitis | Ulcerative Colitis | Drug: Rectal tacrolimus;Drug: Placebo | The University of Western Australia | Royal Brisbane and Women's Hospital;Royal Adelaide Hospital, Australia;Liverpool Hospital, Australia;Fremantle Hospital and Health Service | Completed | 18 Years | N/A | Both | 21 | Phase 4 | Australia |
| 12 | JPRN-UMIN000005824 | 2011/07/01 | 21/06/2011 | Examination of efficacy and safety of tacrolimus, immunomodulator for an outpatient with moderate to severe ulcerative colitis | ulcerative colitis | Tacrolimus (12weeks) | Juntendo University | NULL | Recruiting | 16years-old | 65years-old | Male and Female | 20 | Not applicable | Japan | |
| 13 | JPRN-UMIN000005033 | 2011/03/01 | 01/03/2011 | Open-labeled prospective randomized study between tacrolimus only and tacrolimus with intensive (twice a week) GMA (granulocyte and monocyte absorptive apheresis) for ulcerative colitis | ulcerative colitis | Patients in tacrolimus only receive tacrolimus twice a day (at initial dose of 0.0025mg/kg, optimal serum traff level 10-15ng/ml (until 2 weeks) , 5-10ng/ml (after 2 weeks)) Patiens in tacrolimus with GMA receive tacrolimus twice a day and two GMA treatments per week. | Saitama Medical Center, Saitama Medical University | NULL | Complete: follow-up complete | 12years-old | 75years-old | Male and Female | 50 | Not applicable | Japan | |
| 14 | JPRN-UMIN000003785 | 2010/07/01 | 01/07/2010 | Remission maintenance treatment of ulcerative colitis with tacrolimus in azathioprine-intolerant patients: a randomized comparative trial of 5-aminosalicylic acid (5-ASA) monotherapy versus 5-ASA and tacrolimus combination therapy. | Ulcerative colitis | 5-aminosalicylic acid monotherapy arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). 5-aminosalicylic acid monotherapy and tacrolimus arm: 5-aminosalicylic acid is administered to subjects during the study period (for 48 weeks). Tacrolimus is administered to subjects for 12 weeks after the start of protocol treatment as a rule. | Department of Internal medicine, Division of Lower Gastroenterology, Hyogo College of Medicine | NULL | Complete: follow-up complete | 16years-old | 65years-old | Male and Female | 80 | Phase 3 | Japan | |
| 15 | JPRN-UMIN000003952 | 2010/07/01 | 26/07/2010 | A multicenter, randomised, open-label study to evaluate the clinical efficacy and pharmacokinetics of oral tacrolimus (FK506) therapy under fasting and fed conditions in refractory ulcerative colitis | ulcerative colitis | Fasting condition group: Tacrolimus ingestion 1 hour before meal Fed condition group: Tacrolimus ingestion immediately following consumption of meal | Department of lower gastroenterology, Hyogo College of Medicine | Osaka Medical CollegeOsaka City University | Complete: follow-up complete | 16years-old | Not applicable | Male and Female | 40 | Phase 4 | Japan | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT00347048 (ClinicalTrials.gov) | September 2006 | 30/6/2006 | Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III Placebo-Controlled Double-Blind Study in Moderate to Severe Refractory Ulcerative Colitis Patients | Ulcerative Colitis | Drug: tacrolimus;Drug: Placebo | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 62 | Phase 3 | Japan |
| 17 | NCT00643071 (ClinicalTrials.gov) | September 2006 | 20/3/2008 | Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients | Tacrolimus (FK506) P-III, Open-label Study in Severe Refractory Ulcerative Colitis Patients or Patients Who Attended and Received Placebo in F506-CL-1107 Study | Ulcerative Colitis | Drug: Tacrolimus | Astellas Pharma Inc | NULL | Completed | 16 Years | 64 Years | Both | 32 | Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2011-000176-33-IT (EUCTR) | 14/02/2011 | 23/02/2011 | Cell Therapy Of Duchenne Muscular Dystrophy by intra-arterial delivery of HLA-identical allogeneic mesoangioblasts - ND | Cell Therapy Of Duchenne Muscular Dystrophy by intra-arterial delivery of HLA-identical allogeneic mesoangioblasts - ND | Duchenne Muscolar Dystrophy MedDRA version: 9.1;Level: PT;Classification code 10013801 | INN or Proposed INN: Tacrolimus Product Name: hMABs Other descriptive name: HLA-identical allogeneic mesoangioblasts Product Name: hMABs Other descriptive name: HLA-identical allogeneic mesoangioblasts Product Name: hMABs Other descriptive name: HLA-identical allogeneic mesoangioblasts | FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR | NULL | Authorised-recruitment may be ongoing or finished | Female: no Male: yes | Italy |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00545493 (ClinicalTrials.gov) | November 2002 | 16/10/2007 | Efficacy of Tacrolimus and I.V.-Immunoglobulins in Rasmussen Encephalitis | Efficacy of Tacrolimus and i.v.-Immunoglobulins in Rasmussen Encephalitis With Start of Treatment in the Acute Disease Stage. Prospective, Randomised, Open Parallel Group Study | Rasmussen Encephalitis | Drug: Tacrolimus;Drug: i.v. immunoglobulins | University Hospital, Bonn | Octapharma;Astellas Pharma GmbH | Active, not recruiting | N/A | N/A | Both | 16 | Phase 2;Phase 3 | Germany |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-UMIN000002844 | 2009/09/01 | 03/12/2009 | Development of topical treatment with rapamycin for skin lesions of tuberous sclerosis complex | tuberous sclerosis complex | Application of 0.2% Rapamycin ointment (ointment base is 0.03% tacrolimus ointment) on skin lesion of one side of the face twice a day for 12 weeks. Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks. Application of 0.2% Rapamycin ointment (ointment base is white petrolatum) on skin lesion of one side of the face twice a day for 12 weeks. Application of ointment base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks. Application of 0.2% Rapamycin gel (base is carboxyvinyl polymer) on skin lesion of one side of the face twice a day for 12 weeks. Application of gel base (control) on similar skin lesion of the other side of the face twice a day for 12 weeks. | Department of DermatologyGraduate School of Medicine, Osaka University | NULL | Complete: follow-up complete | Not applicable | Not applicable | Male and Female | 21 | Phase 2;Phase 3 | Japan |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00514982 (ClinicalTrials.gov) | August 7, 2007 | 9/8/2007 | Medical Treatment of Colitis in Patients With Hermansky-Pudlak Syndrome | An Observational Study of the Immunopathogenesis of and Response to Step-Up Inflammatory Bowel Disease Therapy for Hermansky-Pudlak Syndrome-Associated Colitis | Hermanski-Pudlak Syndrome;Colitis;Cytokines;Lymphocytes;Drug Evaluation | Drug: Mesalamine;Drug: Infliximab;Drug: Corticosteroids;Drug: 6-Mercaptopurine;Drug: Tacrolimus;Drug: Adalimumab | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04629248 (ClinicalTrials.gov) | December 31, 2020 | 27/10/2020 | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy | A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy | Primary Membranous Nephropathy | Drug: Obinutuzumab;Drug: Tacrolimus;Drug: Methylprednisolone;Drug: Acetaminophen;Drug: Diphenhydramine | Hoffmann-La Roche | NULL | Not yet recruiting | 18 Years | 75 Years | All | 140 | Phase 3 | United States;Argentina;Brazil;China;Israel;Italy;Poland |
| 2 | ChiCTR2000032422 | 2020-09-01 | 2020-04-27 | The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study | The efficacy and safety of tacrolimus monotherapy in the treatment of idiopathic membranous nephropathy: an open, prospective, real-world study | Idiopathic membranous nephropathy | experimental group:Tacrolimus;control group:conservative treatment; | Shenzhen Second People's Hospital | NULL | Pending | Both | experimental group:24;control group:24; | Phase 4 | Chiina | ||
| 3 | ChiCTR2000033766 | 2020-07-01 | 2020-06-11 | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Diagnostic value of serum C4d, PLA2R, THSD7A antibody in idiopathic membranous nephropathy and analysis of therapeutic effect of tacrolimus | Membranous nephropathy | 1:Prednisone + cyclophosphamide;2:Prednisone + Tacrolimus; | The First Affiliated Hospital of Bengbu Medical College | NULL | Pending | 17 | 70 | Both | 1:30;2:30; | Phase 4 | China |
| 4 | ChiCTR2000032523 | 2020-06-01 | 2020-05-01 | Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial. | Efficacy and safety of rituximab in the treatment of primary membranous nephropathy with type 2 diabetes mellitus: a single-center randomized controlled trial | membranous nephropathy | experimental group:rituximab;control group:tacrolimus; | Xinqiao Hospital | NULL | Pending | 18 | 80 | Both | experimental group:40;control group:40; | Phase 4 | China |
| 5 | ChiCTR2000031003 | 2020-03-25 | 2020-03-20 | Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen | Study and promotion of FSGS treatment based on low concentration tacrolimus optimized immunosuppressive regimen | Idiopathic focal segmental glomerulosclerosis | Tacrolimus group:Low dose of tacrolimus combined with hormone;hormone group:Use hormones; | Southwest Hospital, the First Affiliated Hospital of Army Medical University | NULL | Recruiting | Both | Tacrolimus group:19;hormone group:19; | Phase 4 | China | ||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 6 | ChiCTR1900022943 | 2019-05-03 | 2019-05-04 | Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome | Population Pharmacokinetic Study for Tacrolimus in Pediatric Patients with Primary Nephrotic Syndrome | Nephrotic Syndrome | Case Series:Tacrolimus; | Children's Hospital, Zhejiang University School of Medicine | NULL | Recruiting | Both | Case Series:100; | Phase 4 | China | ||
| 7 | NCT03864250 (ClinicalTrials.gov) | November 26, 2018 | 4/3/2019 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy: A Randomized, Open, Controlled, Multicenter Clinical Trial | Tacrolimus;Idiopathic Membranous Nephropathy;Clinical Trial | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 124 | N/A | China |
| 8 | NCT03549663 (ClinicalTrials.gov) | July 4, 2018 | 10/5/2018 | Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Random, Open, Control and Monocentric Clinical Research on Tacrolimus Monotherapy for Idiopathic Membranous Nephropathy (IMN) | Idiopathic Membranous Nephropathy | Drug: Tacrolimus;Drug: Prednisone | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | NULL | Recruiting | 18 Years | 80 Years | All | 108 | N/A | China |
| 9 | ChiCTR1800016140 | 2018-07-01 | 2018-05-14 | Comparison of the efficacy and safety of tacrolimus and glucocorticoid combined with cyclophosphamide in the treatment of adult primary membranous nephropathy: a multicenter, controlled, open study | A randomized controlled trial for the treatment of primary membranous nephropathy | primary membranous nephropathy | Tacrolimus group:Tacrolimus 0.05-0.1mg/kg/d;Cyclophosphamide group:CTX 750mg/m2 ivgtt q2w for 8 weeks, then q4w for 4 weeks; | Sichuan Provincial People's Hospital | NULL | Pending | 18 | 65 | Both | Tacrolimus group:45;Cyclophosphamide group:45; | China | |
| 10 | ChiCTR1800014719 | 2018-02-01 | 2018-01-31 | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | A retrospective control study of low concentration of tacrolimus combined with prednisone in the treatment of idiopathic focal segmental glomerulosclerosis | idiopathic focal segmental glomerulosclerosis | tacrolimus group:nothing;prednisone group:nothing; | the First Affiliated Hospital of Third Military Medical University | NULL | Recruiting | Both | tacrolimus group:24;prednisone group:17; | China | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 11 | NCT02921789 (ClinicalTrials.gov) | May 22, 2017 | 30/9/2016 | Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients | Kidney Transplantation;Focal Segmental Glomerulosclerosis (FSGS) | Drug: Bleselumab;Drug: Basiliximab;Drug: Mycophenolate Mofetil (MMF);Drug: Tacrolimus Capsules;Drug: Methylprednisone;Drug: Prednisone | Astellas Pharma Global Development, Inc. | Kyowa Kirin Co., Ltd. | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States;Canada |
| 12 | ChiCTR-IPR-16008344 | 2016-04-19 | 2016-04-22 | A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid plus tacrolimus in idiopathic membranous nephropathy | A study for comparing alternating glucocorticoid and cyclophosphamide versus glucocorticoid Plus tacrolimus in idiopathic membranous nephropathy | idiopathic membranous nephropathy | A:cyclophosphamide ;B:tacrolimus; | Baoji Central Hospital | NULL | Recruiting | Both | A:30;B:30; | China | |||
| 13 | EUCTR2013-000226-55-NL (EUCTR) | 04/03/2015 | 24/06/2014 | SEQUENTIAL THERAPY WITH TACROLIMUS AND RITUXIMAB IN PRIMARY MEMBRANOUS NEPHROPATHY | European Multicenter and Open-Label Controlled Randomized Trial to evaluate the Efficacy of Sequential Treatment with Tacrolimus-Rituximab versus Steroids plus Cyclophosphamide in patientes with Primary Membranous Nephropathy - STARMEN | Primary membranous nephropathy MedDRA version: 17.0;Level: LLT;Classification code 10027170;Term: Membranous nephropathy;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Tacrolimus Product Name: TACROLIMUS INN or Proposed INN: TACROLIMUS Other descriptive name: TACROLIMUS Trade Name: MabThera Product Name: Rituximab INN or Proposed INN: RITUXIMAB Trade Name: Methylprednisolone Product Name: Methylprednisolone INN or Proposed INN: methylprednisolone Other descriptive name: METHYLPREDNISOLONE Trade Name: Prednisolone Product Name: Prednisolone INN or Proposed INN: prednisolone Other descriptive name: PREDNISOLONE ACETATE Trade Name: cyclophosphamide Product Name: cyclophosphamide INN or Proposed INN: CYCLOPHOSPHAMIDE | Fundacion Renal Iñigo Alvarez Toledo | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 175 | Spain;Netherlands | |||
| 14 | NCT01955187 (ClinicalTrials.gov) | January 2014 | 19/9/2013 | Sequential Therapy With Tacrolimus and Rituximab in Primary Membranous Nephropathy | European Multicenter and Open-Label Controlled Randomized Trial to Evaluate the Efficacy of Sequential Treatment With Tacrolimus-Rituximab Versus Steroids Plus Cyclophosphamide in Patients With Primary Membranous Nephropathy (The STARMEN Study) | MEMBRANOUS NEPHROPATHY | Drug: TACROLIMUS;Drug: RITUXIMAB;Drug: METHYLPREDNISOLONE;Drug: CYCLOPHOSPHAMIDE | Hospital Universitario 12 de Octubre | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz;Hospital Universitario Fundación Alcorcón;Fundación para la Investigación Biomédica Hospital Universitario 12 de Octubre;Biobanco REDinREN;ERA-EDTA;REDinREN;Sociedad Española de Nefrología;Fundación de Investigación Biomédica - Hospital Universitario de La Princesa;University Hospital, Aachen | Completed | 18 Years | N/A | All | 86 | Phase 3 | Spain |
| 15 | NCT01763580 (ClinicalTrials.gov) | July 16, 2012 | 6/12/2012 | A Study to Evaluate the Effect of Tacrolimus and Corticosteroid Combination Therapy in Patients With Minimal Change Nephrotic Syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf Cap.®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) | MCNS;Minimal Change Nephrotic Syndrome (MCNS) | Drug: Tacrolimus;Drug: Prednisolone | Astellas Pharma Korea, Inc. | NULL | Completed | 16 Years | 78 Years | All | 144 | Phase 4 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 16 | NCT01451489 (ClinicalTrials.gov) | October 13, 2011 | 5/8/2011 | The Efficacy and Safety of Tacrolimus in Treated Refractory Focal Segmental Glomerulosclerosis | A Randomized,Multicentre,Prospective Study on the Tacrolimus(FK506)for Focal Segmental Glomerulosclerosis | FSGS | Drug: FK506;Drug: Cyclophosphamide | Nanjing University School of Medicine | NULL | Terminated | 14 Years | 65 Years | All | 70 | N/A | China |
| 17 | ChiCTR-TRC-11001454 | 2011-08-01 | 2011-08-08 | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | Tacrolimus monotherapy follows intravenous methylprednisolone in adults with minimal change nephrotic syndrome: a prospective, multi-centered, open, randomized, controlled trial | minimal change disease in adults;ICD10:N04.001 | Group A:Tacrolimus orally taken 0.5-1mg q12h for 36w, tape;Group B:prednisone orally taken for 36w, 1.0 mg/kg.d, tape; | Kidney Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University | NULL | Completed | Both | Group A:60;Group B:60; | China | |||
| 18 | NCT01162005 (ClinicalTrials.gov) | July 2010 | 12/7/2010 | Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children | Therapeutic Effect of Tacrolimus on Primary Nephrotic Syndrome in Children | Nephrotic Syndrome | Drug: Tacrolimus | Seoul National University Hospital | Chong Kun Dang Pharmaceutical | Completed | N/A | 18 Years | All | 77 | Phase 4 | Korea, Republic of |
| 19 | NCT01161459 (ClinicalTrials.gov) | June 2010 | 12/7/2010 | Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid | Research Institute of Nephrology, Jinling Hospital | Idiopathic Membranous Nephropathy | Drug: Tripterygium wilfordii;Drug: FK506 | Zhi-Hong Liu, M.D. | NULL | Completed | 18 Years | 65 Years | Both | 100 | N/A | China |
| 20 | EUCTR2007-005410-39-ES (EUCTR) | 11/06/2008 | 08/04/2008 | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | Estudio piloto aleatorizado comparativo de tacrolimus vs ciclofosfamida-prednisona en la nefropatía membranosa idiopática” - MEMTAC | 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. MedDRA version: 9.1;Level: LLT;Classification code 10027170;Term: Membranous nephropathy | Trade Name: Advagraf 0,5mg INN or Proposed INN: tacrolimus Trade Name: Genoxal INN or Proposed INN: ciclofosfamida Trade Name: Dacortín 2,5mg INN or Proposed INN: prednisona Trade Name: Advagraf 1mg INN or Proposed INN: tacrolimus Trade Name: Advagraf 5mg INN or Proposed INN: tacrolimus Trade Name: Dacortín 5mg INN or Proposed INN: prednisona Trade Name: Dacortín 30mg INN or Proposed INN: prednisona | Grupo Catalán de Estudio de enfermedades glomerulares. Sociedad Catalana de nefrología. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Spain | |||
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 21 | ChiCTR-TRC-10001024 | 2008-01-01 | 2010-09-14 | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | Tacrolimus versus Cyclophosphamide for Therapy in steroid-resistant and steroid-dependent primary focal segmental glomerulosclerosis | primary focal segmental glomerulosclerosis | group A:intravenous CTX 0.5-0.75g/m2 Monthly+Oral prednisone (Prednisolone) 0.8mg/kg.d ;group B:Oral FK506 FK506 0.1mg/kg.d+prednisone (Prednisolone) 0.5mg/kg.d ; | Shanghai Jiaotong University Affiliated Ruijin Hospital | NULL | Completed | 18 | 75 | Both | group A:30;group B:30; | China | |
| 22 | NCT00302523 (ClinicalTrials.gov) | March 2006 | 13/3/2006 | Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy | Tacrolimus Treatment of Patients With Idiopathic | Idiopathic Membranous Nephropathy | Drug: Tacrolimus | Nanjing University School of Medicine | NULL | Completed | 18 Years | 60 Years | Both | 16 | N/A | China |
| 23 | NCT00302536 (ClinicalTrials.gov) | March 2006 | 13/3/2006 | Tacrolimus Treatment of Patients With Idiopathic Focal Segmental Glomerulosclerosis | Tacrolimus Treatment of Patients With Idiopathic Focal Segmental | Focal Glomerulosclerosis | Drug: Tacrolimus | Nanjing University School of Medicine | NULL | Withdrawn | 15 Years | 50 Years | Both | 0 | N/A | China |
| 24 | NCT00362531 (ClinicalTrials.gov) | November 2004 | 9/8/2006 | Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Phase 3 Study of Tacrolimus Combined With Prednisone Treatment of Idiopathic Membranous Nephropathy and Nephrotic Syndrome | Idiopathic Membranous Nephropathy;Nephrotic Syndrome | Drug: tacrolimus combined with prednisone | Peking University | NULL | Completed | 18 Years | 70 Years | Both | Phase 2;Phase 3 | NULL | |
| 25 | ChiCTR-TRC-09000539 | 2004-03-01 | 2009-09-30 | Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy | Clinical studies of tacrolimus in idiopathic membranous Nephropathy with nephrotic syndrome therapy | Nephrotic Disease | S:Patients receive tacrolimus combined with prednison for six months;L:Patients receive tacrolimus combined with prednison for 24 months; | Second Hospital of Jilin University | NULL | Completed | 16 | 69 | Both | S:10;L:10; | China | |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
| 26 | EUCTR2015-001039-18-Outside-EU/EEA (EUCTR) | 03/07/2015 | Trial on the therapeutic effect of Tacrolimus in combination with low dosage corticosteroids compared with high dosage corticosteroids only, in patients with minimal change necrotic syndrome | Open-Label, Randomized, Comparative, Multi-Center Clinical Trial on the Therapeutic Effect of Tacrolimus (Prograf [Cap.]®) in Combination With Low-Dose Corticosteroid Compared With High-Dose Corticosteroid Alone in Patients With Minimal-Change Nephrotic Syndrome (MCNS) - T_OPTIMUM study | Minimal change nephrotic syndrome;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Prograf INN or Proposed INN: TACROLIMUS Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE Trade Name: Solondo INN or Proposed INN: PREDNISOLONE Other descriptive name: PREDNISOLONE | Astellas Pharma Korea, Inc. | NULL | NA | Female: yes Male: yes | 152 | Korea, Republic of |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03222687 (ClinicalTrials.gov) | September 1, 2015 | 7/7/2017 | Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis | Off-label Use of Tacrolimus in Children With Henoch-Schönlein Purpura Nephritis: Effectiveness and Safety | Henoch-Schönlein Purpura Nephritis | Drug: tacrolimus;Drug: prednisone | Shandong University | NULL | Completed | N/A | 18 Years | All | 25 | Phase 4 | NULL |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2008-001501-42-FI (EUCTR) | 15/05/2008 | 18/03/2008 | Tacrolimus in the treatment of Painful Bladder Syndrome / Interstitial Cystitis | Tacrolimus in the treatment of Painful Bladder Syndrome / Interstitial Cystitis | Painful bladder syndrome / interstitial cystitis (PBS/IC) MedDRA version: 1;Level: LLT;Classification code 10005063;Term: | Trade Name: Prograf INN or Proposed INN: TACROLIMUS | Jukka Sairanen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Finland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04646356 (ClinicalTrials.gov) | October 20, 2020 | 20/10/2020 | Tacrolimus Crossover Trial for Hereditary Hemorrhagic Telangiectasia (HHT) | Tacrolimus Crossover Trial for Hereditary Hemorrhagic Telangiectasia (HHT) | Hereditary Hemorrhagic Telangiectasia;Epistaxis Nosebleed | Drug: Tacrolimus capsule (low-dose);Drug: Placebo | St. Michael's Hospital, Toronto | United States Department of Defense | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Canada |
| 2 | EUCTR2019-003585-40-NL (EUCTR) | 17/12/2019 | 30/09/2019 | Tacrolimus for bleeding in hereditary hemorrhagic telangiectasia patients | An uncontrolled, open label pilot-study assessing the efficacy in reducing bleeding severity, and the safety of oral tacrolimus in patients with hereditary hemorrhagic telangiectasia - Tacrolimus for bleeding in HHT patients | Gastrointestinal bleeding and epistaxis caused by hereditary hemorrhagic telangiectasia. Hereditary Hemorrhagic Telangiectasia (HHT) is an autosomal dominant inherited disease characterized by mucocutaneous telangiectasis. Telangiectasis predominantly observed in the nasal mucosa and gut, and are abnormal, thin walled blood vessel that can easily rupture leading to hemorrhage. MedDRA version: 20.0;Level: LLT;Classification code 10038554;Term: Rendu-Osler-Weber syndrome;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | St. Antonius Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Phase 2 | Netherlands |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01429844 (ClinicalTrials.gov) | January 2001 | 5/9/2011 | Tacrolimus Versus Cyclosporine for Immunosuppression After Lung Transplantation | Randomized, Open-label, Multi-Center Study Comparing Tacrolimus With Cyclosporin, Both Arms in Combination With Mycophenolate Mofetil and Corticosteroids for Prevention of Bronchiolitis Obliterans Syndrome in Lung Transplant Patients | Bronchiolitis Obliterans;Immunosuppression | Drug: Tacrolimus;Drug: Cyclosporine | Universitätsklinikum Hamburg-Eppendorf | NULL | Completed | 18 Years | 66 Years | Both | 274 | Phase 3 | Australia;Austria;Belgium;Germany;Spain;Switzerland |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03918265 (ClinicalTrials.gov) | May 4, 2019 | 16/4/2019 | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Tacrolimus Treatment for Refractory Autoimmune Cytopenia | Autoimmune Hemolytic Anemia;Pure Red Cell Aplasia;Evans Syndrome | Drug: Tacrolimus | Peking Union Medical College Hospital | NULL | Recruiting | 18 Years | 80 Years | All | 80 | Phase 4 | China |
| 2 | NCT03540472 (ClinicalTrials.gov) | June 10, 2018 | 14/5/2018 | Tacrolimus Treatment for Refractory PRCA | Tacrolimus Treatment for Refractory Pure Red Cell Aplasia, a Prospective Study | Pure Red Cell Aplasia | Drug: tacrolimus | Peking Union Medical College Hospital | NULL | Unknown status | 18 Years | 80 Years | All | 30 | Phase 4 | China |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT01529827 (ClinicalTrials.gov) | February 28, 2012 | 6/2/2012 | Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies | A Phase II Trial of Reduced Intensity Allogeneic Stem Cell Transplantation With Fludarabine, Melphalan and Low Dose Total Body Irradiation | Accelerated Phase Chronic Myelogenous Leukemia;Adult Acute Lymphoblastic Leukemia in Remission;Adult Acute Myeloid Leukemia in Remission;Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities;Adult Acute Myeloid Leukemia With Del(5q);Adult Acute Myeloid Leukemia With Inv(16)(p13;q22);Adult Acute Myeloid Leukemia With t(15;17)(q22;q12);Adult Acute Myeloid Leukemia With t(16;16)(p13;Adult Acute Myeloid Leukemia With t(8;21)(q22;Adult Grade III Lymphomatoid Granulomatosis;Adult Nasal Type Extranodal NK/T-cell Lymphoma;Anaplastic Large Cell Lymphoma;Angioimmunoblastic T-cell Lymphoma;Aplastic Anemia;Burkitt Lymphoma;Childhood Acute Lymphoblastic Leukemia in Remission;Childhood Acute Myeloid Leukemia in Remission;Childhood Chronic Myelogenous Leukemia;Childhood Diffuse Large Cell Lymphoma;Childhood Grade III Lymphomatoid Granulomatosis;Childhood Immunoblastic Large Cell Lymphoma;Childhood Myelodysplastic Syndromes;Childhood Nasal Type Extranodal NK/T-cell Lymphoma;Chronic Myelomonocytic Leukemia;Chronic Phase Chronic Myelogenous Leukemia;Congenital Amegakaryocytic Thrombocytopenia;Diamond-Blackfan Anemia;Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue;Hepatosplenic T-cell Lymphoma;Juvenile Myelomonocytic Leukemia;Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable;Nodal Marginal Zone B-cell Lymphoma;Paroxysmal Nocturnal Hemoglobinuria;Peripheral T-cell Lymphoma;Polycythemia Vera;Post-transplant Lymphoproliferative Disorder;Previously Treated Myelodysplastic Syndromes;Primary Myelofibrosis;Recurrent Adult Acute Lymphoblastic Leukemia;Recurrent Adult Acute Myeloid Leukemia;Recurrent Adult Burkitt Lymphoma;Recurrent Adult Diffuse Large Cell Lymphoma;Recurrent Adult Diffuse Mixed Cell Lymphoma;Recurrent Adult Diffuse Small Cleaved Cell Lymphoma;Recurrent Adult Grade III Lymphomatoid Granulomatosis;Recurrent Adult Hodgkin Lymphoma;Recurrent Adult Immunoblastic Large Cell Lymphoma;Recurrent Adult Lymphoblastic Lymphoma;Recurrent Adult T-cell Leukemia/Lymphoma;Recurrent Childhood Acute Lymphoblastic Leukemia;Recurrent Childhood Acute Myeloid Leukemia;Recurrent Childhood Anaplastic Large Cell Lymphoma;Recurrent Childhood Grade III Lymphomatoid Granulomatosis;Recurrent Childhood Large Cell Lymphoma;Recurrent Childhood Lymphoblastic Lymphoma;Recurrent Childhood Small Noncleaved Cell Lymphoma;Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma;Recurrent Grade 1 Follicular Lymphoma;Recurrent Grade 2 Follicular Lymphoma;Recurrent Grade 3 Follicular Lymphoma;Recurrent Mantle Cell Lymphoma;Recurrent Marginal Zone Lymphoma;Recurrent Mycosis Fungoides/Sezary Syndrome;Recurrent Small Lymphocytic Lymphoma;Recurrent/Refractory Childhood Hodgkin Lymphoma;Refractory Chronic Lymphocytic Leukemia;Refractory Hairy Cell Leukemia;Refractory Multiple Myeloma;Secondary Acute Myeloid Leukemia;Secondary Myelodysplastic Syndromes;Secondary Myelofibrosis;Severe Combined Immunodeficiency;Severe Congenital Neutropenia;Shwachman-Diamond Syndrome;Splenic Marginal Zone Lymphoma;T-cell Large Granular Lymphocyte Leukemia;Waldenstrom Macroglobulinemia;Wiskott-Aldrich Syndrome | Drug: fludarabine phosphate;Drug: melphalan;Radiation: total-body irradiation;Drug: tacrolimus;Drug: mycophenolate mofetil;Drug: methotrexate;Other: laboratory biomarker analysis;Procedure: allogeneic hematopoietic stem cell transplantation;Procedure: peripheral blood stem cell transplantation | Roswell Park Cancer Institute | NULL | Completed | 3 Years | 75 Years | All | 94 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT00053989 (ClinicalTrials.gov) | January 29, 2002 | 5/2/2003 | NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders | Non-Myeloablative Allogeneic Hematopoietic Peripheral Blood Stem Cell Transplantation for Hematologic Malignancies and Disorders | Chronic Myeloproliferative Disorders;Leukemia;Lymphoma;Multiple Myeloma and Plasma Cell Neoplasm;Myelodysplastic Syndromes;Myelodysplastic/Myeloproliferative Diseases;Fanconi Anemia;Aplastic Anemia | Biological: anti-thymocyte globulin;Biological: graft-versus-tumor induction therapy;Biological: sargramostim;Biological: therapeutic allogeneic lymphocytes;Drug: cyclophosphamide;Drug: fludarabine phosphate;Drug: methylprednisolone;Drug: mycophenolate mofetil;Drug: tacrolimus;Procedure: allogeneic bone marrow transplantation;Procedure: peripheral blood stem cell transplantation;Procedure: umbilical cord blood transplantation | Roswell Park Cancer Institute | NULL | Completed | 4 Years | 75 Years | All | 41 | Phase 2 | United States |
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | EUCTR2009-014050-15-BE (EUCTR) | 18/09/2009 | 14/09/2009 | 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 - Tac-XL | 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 - Tac-XL | Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant MedDRA version: 12.0;Level: LLT;Classification code 10025127;Term: Lung transplant | Trade Name: Prograft capsules Product Name: Tacrolimus capsules INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS Trade Name: Advagraf prolonged-release hard capsules Product Name: Tacrolimus prolonged-release hard capsules | Hopital Erasme - Chest service | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 2 | NCT00975663 (ClinicalTrials.gov) | September 2009 | 10/9/2009 | Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation | Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis | Lung and Heart-lung Transplantation | Drug: Tacrolimus and MMF | University Hospital, Limoges | NULL | Terminated | 18 Years | N/A | Both | 180 | Phase 4 | Belgium;France |