drugset / Trial / NCT06365437
A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation
RandomizedSequentialOpen-labelBasic science
Summary
The purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of escalating doses of TCD601 when compared to rATG in de novo renal transplant patients.
Timeline
- Start
- 2021-06-06
- Primary completion
- 2024-12-11
- Completion
- 2024-12-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ATG | Protein / enzyme biologic | 1.5 mg/kg | — |
| Subject | Siplizumab | Monoclonal antibody | 0.2 mg/kg | — |
| Subject | Siplizumab | Monoclonal antibody | 0.6 mg/kg | — |
| Subject | Siplizumab | Monoclonal antibody | 1.7 mg/kg | — |
| Subject | Siplizumab | Monoclonal antibody | 5 mg/kg | — |
| Background | Mycophenolate Mofetil | Small molecule | — | — |
| Background | Tacrolimus | Small molecule | — | — |
Indications
No indication recorded.