drugset / Trial / NCT04114188
Tacrolimus After rATG and Infliximab Induction Immunosuppression (RIMINI)
Phase 2
Completed
68 enrolled
Prof. Dr. Petra Reinke
Institut Klinické a Experimentální Medicíny · collab
NaSingle-groupOpen-labelTreatment
Summary
International multicenter open-label single-arm confidence-interval-estimation based Phase II clinical trial, aiming to estimate a plausible range of the proportion of patients experiencing efficacy failure in the population, to provide evidence for efficacy and safety of the induction regimen with rATG and infliximab and a go/no go rule for further clinical development.
Timeline
- Start
- 2016-12-15
- Primary completion
- 2020-12
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Infliximab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Thymoglobulin | Protein / enzyme biologic | 1.5 mg/kg | — |
| Background | Prednisolone | Other / unclassified | 5 mg | — |
| Background | Tacrolimus | Small molecule | 0.2 mg/kg | — |