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NCT07412470 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
A Phase 2 study, sponsored by Sanofi.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 526
- Enrollment target
NCT07412470: Recruiting Phase 2 study, sponsored by Sanofi.
NCT07412470 is a Phase 2 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 526 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07412470, a Phase 2 study, is actively recruiting participants, sponsored by Sanofi.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 526 participants
- Enrollment target
Study Summary
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.
Primary Outcome
BPAR is defined as biopsy confirmed T cell mediated and antibody mediated rejection as categorized by BANFF 2022; graft loss is defined as the first date the patients meet any of the following criteria: chronic dialysis for a least 56 days, day of allograft nephrectomy, or day of re-transplant.
Interventions
- DRUG Tacrolimus
- DRUG Frexalimab
- DRUG mycophenolate mofetil
- DRUG rabbit anti-thymocyte globulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 526 participants |
| Start Date | 2026-03-13 |
| Est. Completion | 2033-08-15 |
| Phase | Phase 2 |
What NCT07412470 shows while recruiting
NCT07412470 is an interventional study that assigns participants to a tested intervention. The registered 526 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (295% higher).
The record links to 0 conditions, and to 4 interventions - of which Tacrolimus is the first listed.
NCT07412470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07412470 about?
NCT07412470 is a clinical study titled "A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation". 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-t...
What is the current status of trial NCT07412470?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 526 participants. The study started on 2026-03-13. Estimated completion is 2033-08-15.
What interventions are being tested in trial NCT07412470?
The interventions under investigation include: Tacrolimus (DRUG), Frexalimab (DRUG), mycophenolate mofetil (DRUG), rabbit anti-thymocyte globulin (DRUG).
Who is sponsoring clinical trial NCT07412470?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07412470's enrollment target sits among peer trials
526 65th of 2000 higher than 1,936 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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