A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients
| Sponsor: |
Sanofi-Aventis |
| Enrolling: |
Male and Female Patients |
| IRB Number: |
ACYY0421 |
| U.S. Govt. ID: |
NCT07412470 |
| Contact: |
Transplant Clinical Research Center: 212-305-3839 / tcrcstudyreferral@cumc.columbia.edu |
This study is testing whether a new investigational medicine called frexalimab can safely and effectively prevent kidney transplant rejection compared to tacrolimus, a standard medication currently used after transplant. Participants will be randomly assigned to receive either frexalimab (given by injection every 4 weeks) or tacrolimus (taken as capsules twice daily), along with standard anti-rejection medications and steroids. The study will follow participants for about five years, including regular clinic visits, blood tests, and kidney function monitoring to evaluate graft health and overall safety. This research could lead to new treatment options that help protect transplanted kidneys while reducing medication-related side effects. If you have any questions regarding this study, please contact the Transplant Clinical Research Center (TCRC).
Investigator
Lloyd Ratner, MD, MPH, FACS
| Are you at least 18 years of age? |
Yes |
No |
| Are you actively listed on the kidney transplant waiting list for your first kidney transplant? |
Yes |
No |