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.
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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
73 sites in 18 countries
China15 sites, 15 recruiting
- 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
United States14 sites, 14 recruiting
- 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
Italy8 sites, 8 recruiting
- 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
France5 sites, 5 recruiting
- 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
Spain5 sites, 5 recruiting
- 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
Australia4 sites, 4 recruiting
- 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
Brazil4 sites, 4 recruiting
- 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
Sweden3 sites, 3 recruiting
- Recruiting
Investigational Site Number : 7520001
Gothenburg, 413 45
- Recruiting
Investigational Site Number : 7520003
Huddinge, 141 57
- Recruiting
Investigational Site Number : 7520002
Uppsala, 751 85
Argentina2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0320002
Buenos Aires, 1431
- Recruiting
Investigational Site Number : 0320001
Corrientes, 3400
Belgium2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 0560002
Brussels, 1200
- Recruiting
Investigational Site Number : 0560001
Leuven, 3000
Chile2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, 8320325
- Recruiting
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, 8330032
Czechia2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 2030002
Ostrava, 708 52
- Recruiting
Investigational Site Number : 2030001
Prague, 140 21
Netherlands2 sites, 2 recruiting
- Recruiting
Investigational Site Number : 5280001
Groningen, 9713 GR
- Recruiting
Investigational Site Number : 5280002
Leiden, 2333 ZA
Denmark1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2080001
Aarhus, 8200
Finland1 site, 1 recruiting
- Recruiting
Investigational Site Number : 2460001
Helsinki, 00029
Hungary1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3480001
Pécs, 7624
Israel1 site, 1 recruiting
- Recruiting
Investigational Site Number : 3760002
Ramat Gan, 5262100
United Kingdom1 site, 1 recruiting
- Recruiting
Investigational Site Number : 8260001
Birmingham, England, B15 2TH
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.
- Conditions
- Kidney Transplant Rejection
- 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
Pharmaceutical form:Tablet or capsule-Route of administration:Oral
mycophenolate sodiumDrug
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Solution for injection-Route of administration:IV
prednisoneDrug
Pharmaceutical form:Tablet-Route of administration:Oral
| Study group | Role | What they receive |
|---|---|---|
| Frexalimab | Experimental | The 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 |
| Tacrolimus | Active comparator | Tacrolimus 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.
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)
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
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
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
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
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
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
iBox score at 1 year post kidney transplantation
Measured: at 1 year
Composite of participant and graft survival at 5 years post kidney transplantation
Measured: at 5 years
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
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
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
Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation
Measured: up to 5 years
Time to first BPAR
Measured: up to 5 years
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
Incidence of rejection episodes with clinical resolution up to 5 years post kidney transplantation
Measured: up to 5 years
Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation
Measured: by 6 months
Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation
Measured: at 1 year
Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation
Measured: at 5 years
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
Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period
Measured: until 5 years
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
Frexalimab plasma concentration over time
Measured: up to 1 year
Incidence of ADA
Measured: until 5 years
Incidence of new-onset diabetes post kidney transplantation
Measured: until 5 years
Incidence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure
Measured: until 5 years
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
Titer of ADA
Measured: until 5 years
Persistence of ADA
Measured: until 5 years
Prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure
Measured: until 5 years
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
Incidence of chronic allograft nephropathy at 1 year
Measured: At 1 year
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
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
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
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.
- First posted17 Feb 2026
- Study start13 Mar 2026
- Primary completion15 Aug 2029 (estimated)
- Study completion15 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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