A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
← catalyst calendarNCT07412470 · readout in 1,092 d
Sponsored by Sanofi (industry) · SNY — their whole pipeline →.
Phase
Phase 2/3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
526estimated
Sites
26
Countries
Argentina, Australia, Belgium +8
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-03-13 | actual | When the study began enrolling |
| Primary completion | 2029-08-15 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-08-15 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-17 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-23 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Kidney Transplant Rejection
Interventions
- Drug: Frexalimab — also filed as SAR441344
- Drug: Frexalimab — also filed as SAR441344
- Drug: Tacrolimus
- Drug: rabbit anti-thymocyte globulin
- Drug: mycophenolate mofetil
- Drug: mycophenolate sodium
- Drug: methylprednisolone
- Drug: prednisone
Primary outcome
what the primary-completion date above is the date OFComposite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation
measured by 1 year
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