drugset / Trial / NCT01095172
RituxiMab INDuction in Renal Transplantation
Phase 4
Unknown
100 enrolled
Guy's and St Thomas' NHS Foundation Trust
Astellas Pharma Europe Ltd. · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Hypothesis: * That B cell depletion, rather than reducing acute rejection, will allow minimisation of immunosuppression, which may lead to better graft survival. Aim: * To assess whether the addition of rituximab to a low-dose tacrolimus immunosuppression regime allows a reduction in steroid administration. Objectives: * To assess whether B cell depletion affects graft function, acute rejection and complication rates * To assess whether the T cell response to allotransplantation is impaired by B cell depletion.
Timeline
- Start
- 2010-11
- Primary completion
- 2020-10
- Completion
- 2022-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Prednisolone | Other / unclassified | — | — |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Hydrocortisone | Other / unclassified | 100 mg | — |
| Background | Mycophenolate Mofetil | Small molecule | 2 g | — |
| Background | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.