drugset / Trial / NCT03994783
Transplant Antibody-Mediated Rejection: Guiding Effective Treatments
Phase 3
Terminated
3 enrolled
Imperial College London
Cambridge University Hospitals NHS Foundation Trust · collabKidney Cancer UK · collabNational Institute for Health Research, United Kingdom · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This trial evaluates the addition of rituximab to standard of care in the treatment of antibody-mediated rejection in kidney transplant patients. The trial will involve adults and children. Half of participants will receive standard of care (methylprednisolone, intravenous immunoglobulin and plasma exchange), while the other half will receive standard of care and rituximab.
Timeline
- Start
- 2019-07-17
- Primary completion
- 2021-07-17
- Completion
- 2023-01-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 100 mg/kg | Intravenous |
| Background | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 500 mg | Intravenous |
| Background | Methylprednisolone | Other / unclassified | 600 mg/m2 | Intravenous |