MedPath

Basiliximab

Generic Name
Basiliximab
Brand Names
Simulect
Drug Type
Biotech
CAS Number
179045-86-4
Unique Ingredient Identifier
9927MT646M
Background

A recombinant chimeric (murine/human) monoclonal antibody (IgG1k) that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor a-chain (IL-2R alpha, also known as CD25 antigen) on the surface of activated T-lymphocytes. It is a 144 kDa glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2R alpha.

Indication

For prophylactic treatment of kidney transplant rejection

Associated Conditions
Rejection Acute Renal

Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

Phase 3
Completed
Conditions
Liver Transplantation
Interventions
First Posted Date
2009-11-11
Last Posted Date
2024-11-01
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
893
Registration Number
NCT01011205
Locations
🇫🇮

026, Helsinki, Finland

🇧🇾

146, Minsk, Belarus

🇧🇪

006, Gent, Belgium

and more 69 locations

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Phase 2
Completed
Conditions
Myelofibrosis
Anemia, Aplastic
Hemoglobinuria, Paroxysmal
Acute Myelogenous Leukemia
Acute Lymphocytic Leukemia
Chronic Myelogenous Leukemia
Chronic Lymphocytic Leukemia
Myelodysplasia
Non-Hodgkin's Lymphoma
Hodgkin's Disease
Interventions
First Posted Date
2009-09-14
Last Posted Date
2016-02-26
Lead Sponsor
Indiana University School of Medicine
Target Recruit Count
17
Registration Number
NCT00975975
Locations
🇺🇸

Indiana University Cancer Center, Indianapolis, Indiana, United States

Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

Phase 4
Completed
Conditions
Chronic Renal Failure
Interventions
First Posted Date
2009-08-25
Last Posted Date
2014-08-15
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
36
Registration Number
NCT00965094
Locations
🇮🇱

Novartis Investigative Site, Tel-Aviv, Israel

Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

Phase 4
Terminated
Conditions
Renal Transplantation
Interventions
Drug: Enteric Coated Mycophenolic Acid (MPA)
Drug: Corticosteroids
First Posted Date
2009-08-11
Last Posted Date
2014-06-06
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
207
Registration Number
NCT00956293
Locations
🇩🇪

Novartis Investigative Site, München, Germany

Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts

Phase 3
Completed
Conditions
Kidney Transplantation
Interventions
First Posted Date
2009-07-07
Last Posted Date
2024-11-01
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
281
Registration Number
NCT00933231
Locations
🇨🇦

Site CA133 Foothills Medical Centre, Calgary, Alberta, Canada

🇨🇦

Site CA54 University of Alberta Hospital, Edmonton, Alberta, Canada

🇨🇦

Site CA27 London Health Sciences Centre, London, Ontario, Canada

and more 10 locations

Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

Phase 2
Terminated
Conditions
End Stage Renal Disease
Interventions
First Posted Date
2009-06-26
Last Posted Date
2015-02-10
Lead Sponsor
Drexel University College of Medicine
Target Recruit Count
5
Registration Number
NCT00928811
Locations
🇺🇸

Drexel University College of Medicine, Philadelphia, Pennsylvania, United States

Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

Phase 2
Conditions
Liver Transplantation
Chronic Renal Insufficiency
Interventions
First Posted Date
2009-04-29
Last Posted Date
2011-09-15
Lead Sponsor
Armin Goralczyk
Target Recruit Count
29
Registration Number
NCT00890253
Locations
🇩🇪

University Medical Center Goettingen, Goettingen, Germany

Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation

Phase 2
Completed
Conditions
Diabetes Mellitus, Type I
Interventions
First Posted Date
2008-11-11
Last Posted Date
2021-09-28
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
24
Registration Number
NCT00789308
Locations
🇳🇴

University Hospital Rikshospitalet, Oslo, Norway

🇸🇪

Karolinska University Hospital, Stockholm, Sweden

🇸🇪

Uppsala University Hospital, Uppsala, Sweden

A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Phase 2
Withdrawn
Conditions
Kidney Transplantation
Interventions
First Posted Date
2008-08-07
Last Posted Date
2017-06-22
Lead Sponsor
Genentech, Inc.
Registration Number
NCT00729768
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