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Kidney Transplant RejectionPhase 2/3FREXERANCT07412470

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

A Phase 2/3 study testing Frexalimab, Tacrolimus and rabbit anti-thymocyte globulin in people with Kidney Transplant Rejection, run by Sanofi at 73 sites in 18 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Kidney Transplant Rejection
What is being tested?
Frexalimab, Tacrolimus and rabbit anti-thymocyte globulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
526 participants
Where
73 sitesin 18 countries
Study dates
13 Mar 2026to 15 Aug 2033
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.

Trial locations and contacts

73 sites in 18 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

Contact-US@sanofi.com

73 sites in 18 countries

China15 sites, 15 recruiting

  • Investigational Site Number : 1560018

    Beijing, 100050

    Recruiting

  • Investigational Site Number : 1560003

    Chengdu, 610041

    Recruiting

  • Investigational Site Number : 1560007

    Guangzhou, 510080

    Recruiting

  • Investigational Site Number : 1560020

    Guangzhou, 510280

    Recruiting

  • Investigational Site Number : 1560002

    Hangzhou, 310003

    Recruiting

  • Investigational Site Number : 1560012

    Jinan, 250014

    Recruiting

  • Investigational Site Number : 1560017

    Nanchang, 330006

    Recruiting

  • Investigational Site Number : 1560008

    Nanning, 053007

    Recruiting

  • Investigational Site Number : 1560016

    Shanghai, 200032

    Recruiting

  • Investigational Site Number : 1560001

    Shanghai, 200127

    Recruiting

  • Investigational Site Number : 1560011

    Tianjin, 300192

    Recruiting

  • Investigational Site Number : 1560006

    Wuhan, 430030

    Recruiting

  • Investigational Site Number : 1560004

    Xi'an, 710061

    Recruiting

  • Investigational Site Number : 1560005

    Zhengzhou, 450052

    Recruiting

  • Investigational Site Number : 1560009

    Zhengzhou, 450061

    Recruiting

Other trials in China

United States14 sites, 14 recruiting

  • University of Michigan Health System - Ann Arbor- Site Number : 8400022

    Ann Arbor, Michigan, 48109

    Recruiting

  • Emory University Hospital- Site Number : 8400002

    Atlanta, Georgia, 30324

    Recruiting

  • University of Maryland School of Medicine - Baltimore- Site Number : 8400045

    Baltimore, Maryland, 21201

    Recruiting

  • Brigham & Women's Hospital- Site Number : 8400049

    Boston, Massachusetts, 02115

    Recruiting

  • The Ohio State University- Site Number : 8400025

    Columbus, Ohio, 43210

    Recruiting

  • Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010

    Hines, Illinois, 60141

    Recruiting

  • University of Kansas Medical Center- Site Number : 8400044

    Kansas City, Kansas, 66160

    Recruiting

  • The Mount Sinai Hospital- Site Number : 8400027

    New York, New York, 10029

    Recruiting

  • Columbia University Irving Medical Center- Site Number : 8400007

    New York, New York, 10032

    Recruiting

  • Weill Cornell Medical College- Site Number : 8400005

    New York, New York, 10065

    Recruiting

  • VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400004

    Richmond, Virginia, 23298

    Recruiting

  • University of California San Francisco - Parnassus Heights- Site Number : 8400001

    San Francisco, California, 94143

    Recruiting

  • University of Washington Medical Center- Site Number : 8400035

    Seattle, Washington, 98195

    Recruiting

  • Montefiore Medical Center - Moses Campus- Site Number : 8400006

    The Bronx, New York, 10467

    Recruiting

Other trials in United States

Italy8 sites, 8 recruiting

  • Investigational Site Number : 3800003

    Bologna, 40138

    Recruiting

  • Investigational Site Number : 3800009

    Brescia, 25123

    Recruiting

  • Investigational Site Number : 3800010

    Milan, Milano, 20122

    Recruiting

  • Investigational Site Number : 3800005

    Milan, Milano, 20162

    Recruiting

  • Investigational Site Number : 3800011

    Novara, 28100

    Recruiting

  • Investigational Site Number : 3800012

    Palermo, 90133

    Recruiting

  • Investigational Site Number : 3800006

    Rome, Roma, 00133

    Recruiting

  • Investigational Site Number : 3800008

    Torette, Ancona, 60020

    Recruiting

Other trials in Italy

France5 sites, 5 recruiting

  • Investigational Site Number : 2500002

    Bordeaux, 33076

    Recruiting

  • Investigational Site Number : 2500009

    Nantes, 44093

    Recruiting

  • Investigational Site Number : 2500008

    Paris, 75015

    Recruiting

  • Investigational Site Number : 2500001

    Toulouse, 31059

    Recruiting

  • Investigational Site Number : 2500003

    Tours, 37044

    Recruiting

Other trials in France

Spain5 sites, 5 recruiting

  • Investigational Site Number : 7240008

    Barcelona, Catalunya [Cataluña], 08003

    Recruiting

  • Investigational Site Number : 7240001

    Barcelona, Catalunya [Cataluña], 08035

    Recruiting

  • Investigational Site Number : 7240007

    Barcelona, Catalunya [Cataluña], 08036

    Recruiting

  • Investigational Site Number : 7240003

    L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907

    Recruiting

  • Investigational Site Number : 7240005

    Málaga, 29010

    Recruiting

Other trials in Spain

Australia4 sites, 4 recruiting

  • Investigational Site Number : 0360002

    Adelaide, South Australia, 5000

    Recruiting

  • Investigational Site Number : 0360004

    Clayton, Victoria, 3168

    Recruiting

  • Investigational Site Number : 0360001

    Parkville, Victoria, 3050

    Recruiting

  • Investigational Site Number : 0360003

    Sydney, New South Wales, 2050

    Recruiting

Other trials in Australia

Brazil4 sites, 4 recruiting

  • Hospital Geral de Fortaleza - HGF- Site Number : 0760007

    Fortaleza, Ceará, 60150-160

    Recruiting

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760004

    Porto Alegre, Rio Grande do Sul, 90020-090

    Recruiting

  • Hospital do Rim e Hipertensão- Site Number : 0760001

    São Paulo, 04038-002

    Recruiting

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760006

    São Paulo, 05403-000

    Recruiting

Other trials in Brazil

Sweden3 sites, 3 recruiting

  • Investigational Site Number : 7520001

    Gothenburg, 413 45

    Recruiting

  • Investigational Site Number : 7520003

    Huddinge, 141 57

    Recruiting

  • Investigational Site Number : 7520002

    Uppsala, 751 85

    Recruiting

Other trials in Sweden

Argentina2 sites, 2 recruiting

  • Investigational Site Number : 0320002

    Buenos Aires, 1431

    Recruiting

  • Investigational Site Number : 0320001

    Corrientes, 3400

    Recruiting

Other trials in Argentina

Belgium2 sites, 2 recruiting

  • Investigational Site Number : 0560002

    Brussels, 1200

    Recruiting

  • Investigational Site Number : 0560001

    Leuven, 3000

    Recruiting

Other trials in Belgium

Chile2 sites, 2 recruiting

  • Investigational Site Number : 1520005

    Santiago, Reg Metropolitana de Santiago, 8320325

    Recruiting

  • Investigational Site Number : 1520004

    Santiago, Reg Metropolitana de Santiago, 8330032

    Recruiting

Other trials in Chile

Czechia2 sites, 2 recruiting

  • Investigational Site Number : 2030002

    Ostrava, 708 52

    Recruiting

  • Investigational Site Number : 2030001

    Prague, 140 21

    Recruiting

Other trials in Czechia

Netherlands2 sites, 2 recruiting

  • Investigational Site Number : 5280001

    Groningen, 9713 GR

    Recruiting

  • Investigational Site Number : 5280002

    Leiden, 2333 ZA

    Recruiting

Other trials in Netherlands

Denmark1 site, 1 recruiting

  • Investigational Site Number : 2080001

    Aarhus, 8200

    Recruiting

Other trials in Denmark

Finland1 site, 1 recruiting

  • Investigational Site Number : 2460001

    Helsinki, 00029

    Recruiting

Other trials in Finland

Hungary1 site, 1 recruiting

  • Investigational Site Number : 3480001

    Pécs, 7624

    Recruiting

Other trials in Hungary

Israel1 site, 1 recruiting

  • Investigational Site Number : 3760002

    Ramat Gan, 5262100

    Recruiting

Other trials in Israel

United Kingdom1 site, 1 recruiting

  • Investigational Site Number : 8260001

    Birmingham, England, B15 2TH

    Recruiting

Other trials in United Kingdom

About this study

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

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.
Being tested
Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin, mycophenolate mofetil, mycophenolate sodium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FrexalimabDrug

    Also called SAR441344

    Pharmaceutical form:Solution for injection-Route of administration:IV

  • FrexalimabDrug

    Also called SAR441344

    Pharmaceutical form:Solution for injection-Route of administration:SC

  • TacrolimusDrug

    Pharmaceutical form:Capsule-Route of administration:Oral

  • rabbit anti-thymocyte globulinDrug

    Pharmaceutical form:Solution for injection-Route of administration:IV

  • mycophenolate mofetilDrug

    Pharmaceutical form:Tablet or capsule-Route of administration:Oral

  • mycophenolate sodiumDrug

    Pharmaceutical form:Tablet-Route of administration:Oral

  • methylprednisoloneDrug

    Pharmaceutical form:Solution for injection-Route of administration:IV

  • prednisoneDrug

    Pharmaceutical form:Tablet-Route of administration:Oral

Study groups in NCT07412470
Study groupRoleWhat they receive
FrexalimabExperimentalThe first dose of frexalimab will be given intravenously and subsequent doses of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)
Receives: Drug: Frexalimab; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone
TacrolimusActive comparatorTacrolimus
Receives: Drug: Tacrolimus; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation

    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.

    Measured: by 1 year

Secondary outcomes (35)

  1. eGFR at 1 year post kidney transplantation

    eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant

    Measured: at 1 year

  2. eGFR at 6 months, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

    eGFR will be calculated with CKD-EPI 2021 formula, based on the creatinine value, age, and gender of the participant

    Measured: at 6 months, 2 years, 3 years, 4 years, and 5 years

  3. Change of eGFR from Month 3 over time up to 5 years post kidney transplantation

    Measured: from Month 3 over time up to 5 years

  4. Participant status of eGFR > 60 mL/min/1.73 m2 at 1, 2, 3, and 5 years post kidney transplantation

    Measured: at 1, 2, 3, and 5 years

  5. Participant status of eGFR < 60 mL/min/1.73 m² at Month 12 or with a > 10 mL/min/1.73 m² decrease in eGFR from Month 3 to 12

    Measured: from Month 3 to 12

  6. Proteinuria at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

    defined as protein concentration in the urine

    Measured: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  7. iBox score at 1 year post kidney transplantation

    Measured: at 1 year

  8. Composite of participant and graft survival at 5 years post kidney transplantation

    Measured: at 5 years

  9. Composite of participant and graft survival over time and at 6 months, 1 year, 2 years, 3 years, and 4 years post kidney transplantation

    Measured: at 6 months, 1 year, 2 years, 3 years, and 4 years

  10. Death-censored graft survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of graft loss)

    Measured: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  11. Participant survival over time and at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation (including the causes of death)

    Measured: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  12. Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation

    Measured: up to 5 years

  13. Time to first BPAR

    Measured: up to 5 years

  14. Incidence of graft rejection at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post kidney transplantation

    Measured: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years

  15. Incidence of rejection episodes with clinical resolution up to 5 years post kidney transplantation

    Measured: up to 5 years

  16. Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation

    Measured: by 6 months

  17. Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation

    Measured: at 1 year

  18. Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation

    Measured: at 5 years

  19. Participants with AEs, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, ECG, and vital signs during the study period

    Measured: until 5 years

  20. Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period

    Measured: until 5 years

  21. Side effects of immunosuppressive therapy evaluated by MTSOSD-59R score at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study

    Measured: at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study

  22. Frexalimab plasma concentration over time

    Measured: up to 1 year

  23. Incidence of ADA

    Measured: until 5 years

  24. Incidence of new-onset diabetes post kidney transplantation

    Measured: until 5 years

  25. Incidence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure

    Measured: until 5 years

  26. Incidence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol

    Measured: until 5 years

  27. Titer of ADA

    Measured: until 5 years

  28. Persistence of ADA

    Measured: until 5 years

  29. Prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure

    Measured: until 5 years

  30. Prevalence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol

    Measured: until 5 years

  31. Incidence of chronic allograft nephropathy at 1 year

    Measured: At 1 year

  32. HbA1c levels at 3 months, 1, 2, 3, 4, and 5 years post transplantation in non-diabetic participants at baseline.

    Measured: At 3 months, 1, 2, 3, 4, and 5 years

  33. Proportion of baseline non-diabetic participants using insulin and/other anti-diabetic medication at 3 months, 1, 2, 3, 4, and 5 years post transplantation.

    Measured: at 3 months, 1, 2, 3, 4, and 5 years

  34. Incidence of the composite cardiac and cerebrovascular events (cardiovascular death, myocardial infarction, ischemic stroke, and revascularization [surgical or percutaneous] procedures) at 1, 2, 3, 4, 5-year post transplantation.

    Measured: at 1, 2, 3, 4, 5-year

  35. Framingham cardiovascular risk score at 1 year post transplantation

    Measured: at 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start13 Mar 2026
  3. Primary completion15 Aug 2029 (estimated)
  4. Study completion15 Aug 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
\[Specify Complex Design\]
Masking
None (open label)
Enrolment
526 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07412470
Sponsor's protocol ID
EFC18554
Other IDs
2025-521521-33-00, 2025
Acronym
FREXERA
Status last verified
Oct 2026
First submitted
3 Feb 2026
Last updated
13 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Frexalimab, Tacrolimus and rabbit anti-thymocyte globulin in people with Kidney Transplant Rejection, run by Sanofi at 73 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 sites in China, United States, Italy, France, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, Contact-US@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation (time frame: by 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07412470.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.

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