drugset / Trial / NCT04903054
Selective CD28 Blockade in Renal Transplant Recipients
Phase 2
Withdrawn
National Institute of Allergy and Infectious Diseases (NIAID)
Bristol-Myers Squibb · collabPPD Development, LP · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The aim of this study is to evaluate the safety and efficacy of lulizumab, a CD28-specific domain antibody (CD28 dAb), compared to tacrolimus, as the primary immunosuppressant in first-time renal transplant recipients.
Timeline
- Start
- 2022-01-10
- Primary completion
- 2022-09-22
- Completion
- 2022-09-22
Outcome
Outcome not reported
Stopped (Enrollment): “Limited period of availability of a supply of the study drug and difficulties in enrollment”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lulizumab | Unknown | — | Subcutaneous |
| Comparator | Tacrolimus | Small molecule | — | — |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | — | Intravenous |