drugset / Trial / NCT01780844
A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of ASKP1240, an anti-CD40 monoclonal antibody, for the prophylaxis of organ rejection after kidney transplantation. This study will compare the efficacy of basiliximab induction, ASKP1240, mycophenolate mofetil (MMF), and steroids \[calcineurin inhibitor (CNI) avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids). In addition, the study will compare the efficacy of basiliximab induction, ASKP1240, tacrolimus and steroids \[CNI minimization-MMF avoidance\] to the standard of care immunosuppressive regimen (basiliximab induction + tacrolimus + MMF + steroids).
Timeline
- Start
- 2013-03-05
- Primary completion
- 2014-06-30
- Completion
- 2017-01-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 1 g | Intravenous |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Intravenous |
| Subject | bleselumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Methylprednisone | Unknown | — | Intravenous |
| Background | Prednisone | Other / unclassified | — | Oral |
Indications
No indication recorded.