Frexalimab versus tacrolimus to prevent kidney transplant rejection

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

This trial will test whether frexalimab injections given for up to five years work as well and are as safe as tacrolimus capsules at preventing rejection in adults getting their first kidney transplant who have low-to-moderate immune risk.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 526 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sanofi (industry)
• Drugs / interventions: frexalimab
• Locations: 10 sites (Sydney and 9 other locations)
• Trial ID: NCT07412470 on ClinicalTrials.gov

What this trial studies

This open-label, randomized, active-comparator Phase 2/3 trial compares subcutaneous frexalimab given for up to approximately five years with standard oral tacrolimus capsules in adults aged 18–70 receiving their first kidney transplant with low-to-moderate immunologic risk. Participants receive randomized treatment alongside standard adjunctive agents such as rabbit anti-thymocyte globulin induction and mycophenolate, and they are followed with about 38 clinic visits over the treatment and follow-up period. Primary outcomes focus on graft rejection rates and long-term safety and tolerability. The protocol excludes high-immunologic-risk transplants, certain primary kidney diseases, active or latent major infections, and significant comorbidities.

Who should consider this trial

Good fit: Ideal candidates are adults 18–70 receiving their first kidney transplant from a living or deceased donor who are judged to have low-to-moderate immunologic risk and can commit to regular follow-up visits.

Not a fit: Patients with high immunologic risk, prior transplants, grafts from expanded-criteria or donation-after-cardiac-death donors, certain primary diseases (idiopathic FSGS, C3 glomerulopathy, lupus nephritis, thrombotic microangiopathy), active TB/HIV/HBV/HCV, or major comorbidities are excluded or unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, frexalimab could provide an alternative long-term immunosuppression option that maintains graft function while offering a different safety or side-effect profile compared with tacrolimus.

How similar studies have performed: Biologic approaches to transplant immunosuppression have shown promise in prior trials (for example with agents like belatacept), but long-term outcomes versus calcineurin inhibitors vary and remain an active area of research.

Eligibility criteria

Inclusion Criteria:

* Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
* Participants with low to moderate immunological risk.

Exclusion Criteria:

* Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac death.
* Positive T or B cell crossmatch, or positive virtual crossmatch per local practice at screening.
* Participants receiving a kidney graft from HLA-identical living-related donors, or have current or previous solid organ, cell, or multi-organ transplantation, or paired kidney transplantation.
* Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
* Evidence of active or latent TB, HIV, HBV or HCV infection.
* Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
* Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Where this trial is running

Sydney and 9 other locations

• Investigational Site Number : 0360003 — Sydney, Australia (RECRUITING)
• Investigational Site Number : 1560003 — Chengdu, China (RECRUITING)
• Investigational Site Number : 1560017 — Nanchang, China (RECRUITING)
• Investigational Site Number : 1560001 — Shanghai, China (RECRUITING)
• Investigational Site Number : 1560006 — Wuhan, China (RECRUITING)
• Investigational Site Number : 2080001 — Aarhus, Denmark (RECRUITING)
• Investigational Site Number : 7240001 — Barcelona, Barcelona [Barcelona], Spain (RECRUITING)
• Investigational Site Number : 7240003 — L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain (RECRUITING)
• Investigational Site Number : 7240005 — Málaga, Spain (RECRUITING)
• Investigational Site Number : 8260001 — Birmingham, England, United Kingdom (RECRUITING)

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)

Conditions: Kidney Transplant Rejection