drugset / Trial / NCT02201576
Bortezomib in Rejection of Kidney Transplants
Phase 2
Completed
60 enrolled
Assistance Publique - Hôpitaux de Paris
Fondation Centaure · collabURC-CIC Paris Descartes Necker Cochin · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of the study is to assess the efficacy of bortezomib, in association with steroids, plasma exchange, and polyclonal intravenous immunoglobulins, in the treatment of chronic antibody mediated rejection due to donor specific anti-HLA antibodies, in kidney transplant recipients
Timeline
- Start
- 2015-02-11
- Primary completion
- 2020-07-16
- Completion
- 2020-07-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 20 mg | Oral |
| Comparator | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | 2 g/kg | Intravenous |