drugset / Trial / NCT07412470
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this open-label, randomized, active-comparator-controlled study is to determine the efficacy and safety of frexalimab subcutaneous administrations up to 5 years compared to tacrolimus capsules in adults undergoing kidney transplantation. Participants aged 18 to 70 years who have low-to-moderate immunologic risk of graft rejection and receive their first kidney transplant are eligible if they meet all inclusion and no exclusion criteria. Study details include: * The study and treatment duration will be up to approximately 5 years. * The number of visits will be approximately 38.
Timeline
- Start
- 2026-03-13
- Primary completion
- 2029-08-15
- Completion
- 2033-08-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Frexalimab | Monoclonal antibody | — | Intravenous |
| Comparator | Tacrolimus | Small molecule | — | Oral |
| Background | Methylprednisolone | Other / unclassified | — | Intravenous |
| Background | Mycophenolate Mofetil | Small molecule | — | Oral |
| Background | Mycophenolate Sodium | Unknown | — | Oral |
| Background | Prednisone | Other / unclassified | — | Oral |
| Background | Thymoglobulin | Protein / enzyme biologic | — | Intravenous |