A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients
A study to investigate the efficacy and safety of frexalimab versus tacrolimus in adults undergoing kidney transplantation
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
Additional Study Information: 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
Do You Qualify?
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
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For more information, please contact:
Transplant Clinical Research Center
tcrcstudyreferral@cumc.columbia.edu
212-305-3839