Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07412470 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation

Study acronym: FREXERA
StatusRecruiting
PhasePhase 2/3
SponsorSanofi
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 63 → 73 locations
  2. Trial sites expanded: 26 → 63 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints revised (35)
  3. Trial sites expanded: 23 → 26 locations
    • Secondary endpoints: 30 to 35
    v6
  4. Trial sites expanded: 16 → 23 locationsv5
  5. Trial sites expanded: 10 → 16 locationsv4
  6. Trial sites expanded: 2 → 10 locationsv3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date changed from estimate of Mar 2, 2026 to Mar 13, 2026
    v2
  8. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sanofi
284 trials monitored
See 12 trials at risk
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.
Trial Details
NCT Number NCT07412470
Lead Sponsor Sanofi
Conditions
(from sponsor)		 Kidney Transplant Rejection
Enrollment 526 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov