drugset / Trial / NCT04066114
Treg Modulation With CD28 and IL-6 Receptor Antagonists
Phase 1/2
Completed
24 enrolled
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb · collabClinical Trials in Organ Transplantation · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety of using lulizumab pegol with tocilizumab, belatacept, and everolimus in kidney transplant recipients.
Timeline
- Start
- 2019-12-11
- Primary completion
- 2023-09-14
- Completion
- 2023-09-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lulizumab pegol | Monoclonal antibody | 12.5 mg | Subcutaneous |
| Background | Belatacept | Protein / enzyme biologic | 5 mg/kg | Intravenous |
| Background | Everolimus | Small molecule | 0.75 mg | Oral |
| Background | Methylprednisolone | Other / unclassified | 125 mg | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | 1000 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | 6 mg/kg | — |
| Background | Tocilizumab | Monoclonal antibody | 162 mg | Intravenous |
| Background | mycophenolic acid | Small molecule | 720 mg | Oral |