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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 is a Phase 2 study that is actively recruiting participants, run by Sanofi. The registered enrollment target is 526 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07412470
The ClinicalTrials.gov registry entry for NCT07412470 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 526 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Tacrolimus is the first listed.
NCT07412470 reports 0 study locations.
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.
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