drugset / Trial / NCT00771875
Randomized Trial for Mixed Acute Rejection
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is being conducted to determine how safe and effective using an immune cell (b cell) depleting therapy and/or Thymoglobulin is in patients with a kidney transplant who are experiencing certain types of rejection.
Timeline
- Start
- 2008-09
- Primary completion
- 2012-12
- Completion
- 2013-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bortezomib | Small molecule | 1.3 mg/m2 | Intravenous |
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | — |
| Background | Acetaminophen | Small molecule | — | — |
| Background | Diphenhydramine | Unknown | — | — |
| Background | Methylprednisolone | Other / unclassified | 125 mg | Intravenous |
| Comparator | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |