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Looking for participantsPhase2/Phase3

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

Sponsor: Sanofi

NCT ID: NCT07412470

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Frexalimab (drug), Frexalimab (drug), Tacrolimus (drug), rabbit anti-thymocyte globulin (drug)
How long the study runs
Study runs about 89 months (dates as stated)
About the drug or intervention
Frexalimab — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · Frexalimab — drug: Pharmaceutical form:Solution for injection-Route of administration:SC · Tacrolimus — drug: Pharmaceutical form:Capsule-Route of administration:Oral · rabbit anti-thymocyte globulin — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · mycophenolate mofetil — drug: Pharmaceutical form:Tablet or capsule-Route of administration:Oral · mycophenolate sodium — drug: Pharmaceutical form:Tablet-Route of administration:Oral · methylprednisolone — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · prednisone — drug: Pharmaceutical form:Tablet-Route of administration:Oral
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 70 Years
Who
All
Number of participants
526
Started
2026-03-13
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for kidney transplant rejection
  • • Phase2/Phase3 - 526 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 70 Years
  • • Diagnosed with kidney transplant rejection

Where?

  • • Birmingham - Investigational Site Number : 8260001

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Kidney Transplant Rejection

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 70 Years
  • Who can join: All genders

Biomarkers mentioned

or positive

What the study is looking for

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

Who cannot take part

  • ✗Deceased donor kidney graft qualified as expanded criteria donor or donor after heart 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...
  • ✗Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic...
  • ✗Evidence of active or latent TB, HIV, HBV or HCV infection.
See the full 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 Is This Study? (1 UK site)

Investigational Site Number : 8260001

Birmingham B15 2TH, United Kingdom

Recruiting

How to Get in Touch

Trial Transparency email recommended (Toll free for US & Canada)

Sponsor contact

CONTACT

800-633-1610 Contact-US@sanofi.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-09