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

Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

Phase 3
Completed
Conditions
Liver Transplant
First Posted Date
2005-10-14
Last Posted Date
2010-09-01
Lead Sponsor
Novartis
Target Recruit Count
194
Registration Number
NCT00238901

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.

Phase 2
Completed
Conditions
Acute Renal Allograft Rejection
Cadaveric Donor Renal Transplantation
Induction Therapy
Interventions
Biological: Thymoglobulin [Anti-thymocyte Globulin (rabbit)]
First Posted Date
2005-10-10
Last Posted Date
2015-03-18
Lead Sponsor
Genzyme, a Sanofi Company
Target Recruit Count
240
Registration Number
NCT00235300
Locations
🇺🇸

UCLA School of Medicine, Los Angeles, California, United States

🇺🇸

Florida Hospital Medical Center and Translife, Orlando, Florida, United States

🇺🇸

Emory University Hospital, Atlanta, Georgia, United States

and more 25 locations

Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

Phase 3
Completed
Conditions
Alpha-1 Antitrypsan Deficiency
COPD
Emphysema
Interventions
Other: placebo
First Posted Date
2005-09-16
Last Posted Date
2017-05-04
Lead Sponsor
University Health Network, Toronto
Target Recruit Count
22
Registration Number
NCT00188825
Locations
🇨🇦

Toronto General Hospital, Toronto, Ontario, Canada

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

Phase 3
Completed
Conditions
Organ Transplantation, Renal Transplantation
Interventions
First Posted Date
2005-09-12
Last Posted Date
2018-08-09
Lead Sponsor
Novartis
Target Recruit Count
114
Registration Number
NCT00154284

Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

Phase 3
Completed
Conditions
Liver Transplantation
Infection
Interventions
Drug: Cyclosporine/cyclosporine microemulsion
Drug: Steroid
First Posted Date
2005-09-08
Last Posted Date
2011-09-22
Lead Sponsor
Novartis
Target Recruit Count
77
Registration Number
NCT00149890
Locations
🇩🇪

Novartis Investigational Site, Various Cities, Germany

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

First Posted Date
2005-09-08
Last Posted Date
2011-04-12
Lead Sponsor
Novartis Pharmaceuticals
Target Recruit Count
171
Registration Number
NCT00149994
Locations
🇨🇭

Novartis, Basel, Switzerland

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

First Posted Date
2005-06-08
Last Posted Date
2011-08-11
Lead Sponsor
Astellas Pharma Inc
Target Recruit Count
501
Registration Number
NCT00113269

Steroid Withdrawal in Pediatric Kidney Transplant Recipients

First Posted Date
2001-08-31
Last Posted Date
2016-10-21
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
274
Registration Number
NCT00023244
Locations
🇺🇸

University of Florida Health Science Center, Jacksonville, Florida, United States

🇺🇸

The Children's Hospital of Buffalo, Buffalo, New York, United States

🇺🇸

Westchester Medical Center, Valhalla, New York, United States

and more 16 locations
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