EFC18554 (FREXERA)
Research type
Research Study
Full title
A seamless Phase 2/3 randomized, open-label study to investigate efficacy and safety of frexalimab versus tacrolimus in adult kidney transplant recipients.
IRAS ID
1012969
Contact name
Patrick Maury
Contact email
Sponsor organisation
Sanofi-Aventis Recherche & Developpement
Research summary
This international study, planned to begin in February 2026 across 23 countries, investigates frexalimab as an investigational treatment to prevent kidney transplant rejection. Currently, over half of transplanted kidneys are rejected within 10 years when the immune system attacks the new organ (graft).
This 5-year, open-label, 2-arm trial compares frexalimab against tacrolimus (standard treatment). Participants undergo:
• Screening (Days -45 to -1)
• Randomisation and transplant (Day 1)
• Treatment period (Day 1 to Year 5)
Treatment assignment is randomised by computer. Both groups also receive mycophenolate and corticosteroids to support graft acceptance.
The primary endpoint is the number of participants experiencing graft rejection or death within 1 year post-transplant.
The secondary endpoints include:
• Kidney function (blood filtration) at 1 year
• Percentage of participants with side effects
Frexalimab targets and blocks CD40 ligand protein, potentially reducing immune response against the transplanted kidney. The first dose is administered intravenously; subsequent doses are subcutaneous injections. Tacrolimus, the comparator, is given as oral tablets twice a day.
Who may participate? People aged 18 to 70 years planned to receive a new kidney.
Who cannot participate? People with certain current medical problems and medications, or medical history, that makes them unsuitable for the study.
Frexalimab's benefits for preventing graft rejection remain unknown. However, it shows good tolerability in ongoing trials for immune diseases and demonstrates effectiveness in reducing brain lesions in multiple sclerosis patients.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
25/EE/0251
Date of REC Opinion
22 Dec 2025
REC opinion
Further Information Favourable Opinion