Simulect (basiliximab) / Novartis  >>  Phase 2
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40 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Simulect (basiliximab) / Novartis
NCT02921789: Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

Completed
2a
67
Canada, US
Bleselumab, ASKP1240, Basiliximab, Simulect®, Mycophenolate Mofetil (MMF), CellCept®, MMF, Tacrolimus Capsules, Prograf®, Methylprednisone, Prednisone
Astellas Pharma Global Development, Inc., Kyowa Kirin Co., Ltd.
Kidney Transplantation, Primary Focal Segmental Glomerulosclerosis (FSGS)
12/20
05/21
NCT00235300: An Open-label, Prospective, Randomized, Multi-center, Phase II Comparative Trial of Thymoglobulin Versus Simulect for the Prevention of Delayed Graft Function and Acute Allograft Rejection in Renal Allograft Recipients.

Completed
2
240
US, Europe
Thymoglobulin [Anti-thymocyte Globulin (rabbit)], Simulect (basliximab)
Genzyme, a Sanofi Company
Cadaveric Donor Renal Transplantation, Acute Renal Allograft Rejection, Induction Therapy
04/03
06/05
NCT00023244: Steroid Withdrawal in Pediatric Kidney Transplant Recipients

Terminated
2
274
US, RoW
Basiliximab, Simulect, Anti-CD25 monoclonal antibody, chimeric, Cyclosporine, CsA, Tacrolimus, Sirolimus, Methylprednisolone, Prednisone, Bactrim, TMP SMX, trimethoprim/sulfamethoxazole
National Institute of Allergy and Infectious Diseases (NIAID), Cooperative Clinical Trials in Pediatric Transplantation
End-Stage Renal Disease
06/05
06/05
NCT00409656: Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients

Completed
2
Europe
Basiliximab
University Hospital Freiburg
Corneal Transplantation
 
12/05
NCT00430898 / 2006-004303-19: Basiliximab in Moderate to Severe Ulcerative Colitis

Completed
2
181
US, Europe, RoW
Basiliximab, Simulect
Cerimon Pharmaceuticals
Ulcerative Colitis
09/08
09/08
BSX-003, NCT00646425: The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis

Terminated
2
5
US
Basiliximab, Simulect, Placebo
Cerimon Pharmaceuticals, PPD
Non-infectious Uveitis
11/08
11/08
NCT01061996 / 2006-006319-54: Basiliximab Maintenance in Ulcerative Colitis

Terminated
2
88
Europe
Basiliximab, Simulect
Cerimon Pharmaceuticals
Ulcerative Colitis
12/08
12/08
NCT00790439: Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant

Withdrawn
2
0
US
Low Molecular Weight Sulfated Dextran, LMW-SD, Heparin, Heparin Sodium, Mycophenolate Mofetil, MMF, Mycophenolate, Mycophenolic Acid, CellCept, Sirolimus, Rapamune, Tacrolimus, Hecoria, Cyclosporine, Ciclosporin, GENGRAF® Capsules, Daclizumab, Basiliximab, Simulect ®, Allogeneic Pancreatic Islet Cells
National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Type I
10/09
10/09
NCT00555321 / 2007-002125-68: Belatacept in Liver Transplant Recipients

Terminated
2
260
US, Canada, Europe, RoW
Tacrolimus, Basiliximab, Belatacept More Intensive (MI), Belatacept Less Intensive (LI), Mycophenolate Mofetil (MMF)
Bristol-Myers Squibb
Immunosuppression in Solid Organ Transplant
03/10
06/11
NCT00543569: A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

Completed
2
323
US
Alefacept, Amevive, ASP0485, tacrolimus, Prograf, FK506, basiliximab, Simulect, mycophenolate mofetil, CellCept, MMF, Corticosteroids
Astellas Pharma Inc
Kidney Transplantation
02/11
02/11
NCT00504543 / 2006-004540-23: Efficacy, Safety and Tolerability of AEB071 Versus Cyclosporine in the Novo Renal Transplant Recipients

Completed
2
311
Europe, RoW
AEB071, Certican, Neoral
Novartis Pharmaceuticals
Kidney Transplantation
04/11
04/11
NCT00434850: Peritransplant Deoxyspergualin in Islet Transplantation in Type 1 Diabetes

Completed
2
14
US
Allogeneic Pancreatic Islet Cells, Deoxyspergualin, Antithymocyte globulin, Daclizumab or basiliximab, Sirolimus, Tacrolimus, Etanercept
National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Diabetes Mellitus, Type 1
09/11
11/13
NCT00464555: Strategies to Improve Islet Survival

Completed
2
5
US
Islet transplant, Antithymocyte globulin, Basiliximab, Lisofylline, Sirolimus, Tacrolimus
National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type 1 Diabetes Mellitus
11/11
02/14
CILT, NCT00890253 / 2008-008754-23: Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

Unknown status
2
29
Europe
Basiliximab (Simulect), Basiliximab: Simulect, Myfortic, Enteric-coated mycophenolate sodium: EC-MPS, Myfortic, everolimus, Certican, Prednisolone, Prednisone
Armin Goralczyk
Liver Transplantation, Chronic Renal Insufficiency
01/12
01/13
LEEP, NCT00468403: LEA29Y (Belatacept) Emory Edmonton Protocol

Completed
2
10
US, Canada
Allogeneic Pancreatic Islet Cells, Belatacept, NUJOLIX, Basiliximab, Simulect, Mycophenolate Mofetil, Cellcept, Tacrolimus, Prograf, Intraportal infusion of islet cells
National Institute of Allergy and Infectious Diseases (NIAID), Clinical Islet Transplantation Consortium
Type 1 Diabetes Mellitus
04/12
04/13
NCT00820911 / 2008-000531-18: Efficacy and Safety of AEB071 Versus Cyclosporine in de Novo Renal Transplant Recipients

Completed
2
175
Europe, RoW
cyclosporine (reduced exposure) / everolimus, AEB071 300 mg b.i.d. / everolimus, AEB071 200 mg b.i.d. / everolimus
Novartis Pharmaceuticals
Kidney Transplantation
07/12
07/12
NCT00975975: Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Completed
2
17
US
Basiliximab, Simulect
Indiana University School of Medicine
Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia, Chronic Myelogenous Leukemia, Chronic Lymphocytic Leukemia, Myelodysplasia, Non-Hodgkin's Lymphoma, Hodgkin's Disease, Multiple Myeloma, Myelofibrosis, Anemia, Aplastic, Hemoglobinuria, Paroxysmal
10/12
11/13
IDEALE, NCT01596062 / 2010-024231-16: Pharmacodynamics, Efficacy and Safety of Basiliximab 40 or 80 mg in Combination With Ciclosporine Microemulsion or Everolimus, in Adult Low Risk de Novo Renal Transplant Recipients ( Study)

Completed
2
16
Europe
Simulect®, Basiliximab, Neoral®, Cyclosporine microemulsion, Certican®, Everolimus, Myfortic®, mycophenolate sodium, Corticosteroids
Novartis Pharmaceuticals
Renal Transplantation
03/13
03/13
NCT01469390: Pharmacodynamics, Efficacy, Safety of Basiliximab 40 or 80 mg Combined With CsA or Everolimus, in Low Risk de Novo Renal Transplant Recipients

Not yet recruiting
2
50
Europe
Basiliximab, Simulect
Novartis Pharmaceuticals
Renal Transplantation
04/13
 
NCT00789308 / 2008-001210-25: Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation

Completed
2
24
Europe
Low Molecular Weight Sulfated Dextran (LMW-SD), Heparin, CellCept® (Mycophenolate mofetil) OR Rapamune® (Sirolimus), Prograf® (Tacrolimus) OR Cyclosporine, Thymoglobulin® (Anti-thymocyte Globulin) - at first transplant, Simulect® (Basiliximab) - at 2nd or 3rd transplant, Klexane® (Enoxaparinsodium), Trombyl® or Albyl-E® (Acetylsalicylicacid- ASA), Enbrel® (Etanercept)
National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Clinical Islet Transplantation Consortium
Diabetes Mellitus, Type I
07/13
08/14
NCT01780844: A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

Completed
2
149
US
ASKP1240, Tacrolimus, Prograf®, Mycophenolate Mofetil (MMF), CellCept®, Basiliximab, Simulect®, Methylprednisone, Prednisone
Astellas Pharma Global Development, Inc., Kyowa Kirin Co., Ltd.
Kidney Transplantation
06/14
01/17
NCT01436305: Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Terminated
2
19
US
Alemtuzumab, Campath®, MMF, mycophenolate mofetil, CellCept®, Basiliximab, Simulect®, Short-term Tac, tacrolimus, Prograf®, Belatacept, Nulojix®, methylprednisolone, MEDROL®
National Institute of Allergy and Infectious Diseases (NIAID), Clinical Trials in Organ Transplantation
Kidney Transplantation, Renal Transplantation
04/15
04/15
NCT01485055: Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Terminated
2
11
US
Infliximab and Basiliximab, Simulect, Remicade, Monoclonal antibody
Nationwide Children's Hospital
Graft Versus Host Disease, Steroid Refractory GVHD, Acute GVH Disease
12/15
09/16
NCT01884571: Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

Completed
2
31
US
Basiliximab, Simulect, Methylprednisolone, Solumedrol, Prednisone, Deltasone, Orasone, Tacrolimus, Prograf, Mycophenolate mofetil, Cellcept
Emory University, ALS Association
Amyotrophic Lateral Sclerosis (ALS)
01/16
01/16
NCT01856257: Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Terminated
2
71
US
Anti-thymocyte Globulin (Rabbit), Thymoglobulin®, ATG (Rabbit), belatacept, NULOJIX®, methylprednisolone, Medrol®, basiliximab, Simulect®, mycophenolate mofetil, MMF, CellCept®, mycophenolate acid, tacrolimus, Prograf®
National Institute of Allergy and Infectious Diseases (NIAID), Clinical Trials in Organ Transplantation
Primary Renal Allograft Candidate, Kidney Transplantation
04/16
04/16
NCT02723786 / 2015-002812-33: Efficacy, Safety, Tolerability and Pharmacokinetic (PK) Study of GSK1070806 for the Prevention of Delayed Graft Function (DGF) in Adult Subjects After Renal Transplantation

Terminated
2
7
Europe
GSK1070806, 1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids
GlaxoSmithKline
Kidney Transplantation (Status Post)
03/17
03/18
NCT02770430: Mesenchymal Stem Cells as First Treatment Line for Resistant Acute Graft Versus Host Disease

Unknown status
2
90
RoW
mesenchymal stem cells, mesenchymal stomal cells, conventional treatment, Basiliximab and/or Infliximab
Hospital de Clinicas de Porto Alegre
Graft vs Host Disease
09/17
12/18
NCT03192657: Basiliximab Treating Interstitial Pneumonia of CADM

Unknown status
2
100
RoW
Basiliximab, Calcineurin Inhibitors, Steroids
RenJi Hospital
Lung; Disease, Interstitial, With Fibrosis, Dermatomyositis
06/19
06/20
ELEVATE, NCT02366728: DC Migration Study for Newly-Diagnosed GBM

Completed
2
64
US
Unpulsed DCs, Unpulsed DCs pre-conditioning, Td, Td toxoid, Td pre-conditioning, Human CMV pp65-LAMP mRNA-pulsed autologous DCs, CMV-specific dendritic cell vaccine, DCs, 111In-labeled DCs, Temozolomide, Temodar, TMZ, Saline, Basiliximab
Mustafa Khasraw, MBChB, MD, FRCP, FRACP
Glioblastoma, Astrocytoma, Grade IV, Giant Cell Glioblastoma, Glioblastoma Multiforme
10/20
10/20
NCT02464878: Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

Completed
2
2
US
Alpha 1-Antitrypsin, Glassia, Islet Transplantation, Thymoglobulin, Antithymocyte Globulin, Basiliximab, Etanercept, Enbrel
Massachusetts General Hospital, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Iowa
Kidney Transplant, Type 1 Diabetes
11/22
12/22
NCT04337593: Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Not yet recruiting
2
20
NA
Basiliximab, anti-CD25 antibody, Pegaspargase
Beijing Tongren Hospital
Extranodal NK/T-cell Lymphoma
05/22
12/22
FWCSWG-IL-2, NCT05013034: Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

Not yet recruiting
2
300
NA
Basiliximab Injection, Simulect, Placebo
Fort Worth Clinical Sciences Working Group, TCU and UNTHSC School of Medicine
SARS-CoV-2 Acute Respiratory Disease, SARS-CoV2 Infection, Cytokine Storm
10/22
12/22
NCT06480630: Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

Not yet recruiting
2
39
RoW
Basiliximab
Anhui Provincial Hospital
Acute Graft Versus Host Disease, Malignant Hematologic Neoplasm
06/26
06/27
NCT04871607: Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma

Recruiting
2
33
US
Basiliximab, SDZ-CHI-621, Simulect, Carmustine, BCNU, Becenum, Becenun, BiCNU, Bis(chloroethyl) Nitrosourea, Bis-Chloronitrosourea, Carmubris, Carmustin, Carmustinum, FDA 0345, N,N'-Bis(2-chloroethyl)-N-nitrosourea, Nitrourean, Nitrumon, SK 27702, SRI 1720, WR-139021, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Etoposide, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP-16, VP-16-213, VP16, Genetically Engineered Hematopoietic Stem Progenitor Cells, Genetically Engineered HSPCs, Recombinant Granulocyte Colony-Stimulating Factor, Recombinant Colony-Stimulating Factor 3, rhG-CSF, Yttrium Y 90 Basiliximab, 90Y Basiliximab, Yttrium Y 90-DOTA-Basiliximab
City of Hope Medical Center, National Cancer Institute (NCI)
Recurrent Hodgkin Lymphoma, Refractory Hodgkin Lymphoma
10/27
10/27
ACTRN12605000802606: SHIRT (Salvage Hodgkins Immunoradiotherapy)

Recruiting
1/2
10
 
South Metropolitan Area Health Service WA, Physician Sponsored
Lymphoproliferative Malignancies (Relapsed or Refractory)
 
 
NCT00492869 / 2006-004128-35: Efficacy and Safety of AEB071 Versus Tacrolimus in Combination With Mycophenolate Acid Sodium, Basiliximab and Steroids in Preventing Acute Rejection After Kidney Transplantation

Completed
1/2
124
Europe, Canada, US
AEB071
Novartis Pharmaceuticals
Kidney Transplantation
05/08
 
NCT00752479 / 2009-012350-20: Mesenchymal Stem Cells Under Basiliximab/Low Dose RATG to Induce Renal Transplant Tolerance

Terminated
1/2
4
Europe
Mesenchymal stem cells infusion, Basiliximab,Methylprednisolone,RATG ,Cyclosporine ,Mycophenolate mofetil, Basiliximab, Methylprednisolone,RATG,Cyclosporine,Mycophenolate mofetil
Mario Negri Institute for Pharmacological Research
Kidney Transplant
07/13
12/13
NCT02561767: Effect of BM-MSCs in DCD Kidney Transplantation

Unknown status
1/2
120
RoW
bone marrow-derived mesenchymal stem cells, BM-MSCs, Saline, Induction therapy (ATG or Basiliximab), ATG or Basiliximab, Maintenance therapy (Low-dose CNI + MPA + steroids), Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids
First Affiliated Hospital, Sun Yat-Sen University, Second Affiliated Hospital of Guangzhou Medical University
Kidney Transplantation, Acute Kidney Tubular Necrosis
10/16
10/17
NCT02492490: Effect of SVF Derived MSC in DCD Renal Transplantation

Unknown status
1/2
120
RoW
SVFderived MSC transplantations, Basiliximab
Fuzhou General Hospital
Uremia
11/16
11/16
NCT02492308: Induction With SVF Derived MSC in Living-related Kidney Transplantation

Unknown status
1/2
120
RoW
SVF-MSC induction, Basiliximab induction
Fuzhou General Hospital
Living-relative Kidney Transplantation
12/16
12/17

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