A Phase 2/3 interventional study of Frexalimab and Frexalimab in Kidney Transplant Rejection, sponsored by Sanofi. Recruiting at 73 sites in 18 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Sanofi · Phase 2/3, Interventional, and Treatment
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:
Sanofi is the lead sponsor of 1,557 studies on the registry; 91 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 123 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The first dose of frexalimab will be given intravenously and subsequent doses of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)
Drug: Frexalimab · Drug: rabbit anti-thymocyte globulin · Drug: mycophenolate mofetil · Drug: mycophenolate sodium · Drug: methylprednisolone · Drug: prednisone
Tacrolimus
Drug: Tacrolimus · Drug: rabbit anti-thymocyte globulin · Drug: mycophenolate mofetil · Drug: mycophenolate sodium · Drug: methylprednisolone · Drug: prednisone
Pharmaceutical form:Solution for injection-Route of administration:IV
Also known as: SAR441344
Pharmaceutical form:Solution for injection-Route of administration:SC
Also known as: SAR441344
Pharmaceutical form:Capsule-Route of administration:Oral
Pharmaceutical form:Solution for injection-Route of administration:IV
Pharmaceutical form:Tablet or capsule-Route of administration:Oral
Pharmaceutical form:Tablet-Route of administration:Oral
Pharmaceutical form:Solution for injection-Route of administration:IV
Pharmaceutical form:Tablet-Route of administration:Oral
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.
Time frame: by 1 year
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
iBox score at 1 year post kidney transplantation
Time frame: at 1 year
Composite of participant and graft survival at 5 years post kidney transplantation
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: up to 5 years
Time to first BPAR
Time frame: 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
Time frame: 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
Time frame: up to 5 years
Composite efficacy failure rate (BPAR, graft loss, and death) by 6 months post kidney transplantation
Time frame: by 6 months
Incidence of de novo donor-specific antibodies at 1 year post kidney transplantation
Time frame: at 1 year
Incidence of de novo donor-specific antibodies at 5 years post kidney transplantation
Time frame: 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
Time frame: until 5 years
Participants with medical device AEs, ADEs, medical device SAEs, SADEs, and device deficiencies during the study period
Time frame: 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
Time frame: at Months 1, 2, 3, 4, 5, 6 and then every 6 months until the end of the study
Frexalimab plasma concentration over time
Time frame: up to 1 year
Incidence of ADA
Time frame: until 5 years
Incidence of new-onset diabetes post kidney transplantation
Time frame: until 5 years
Incidence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure
Time frame: until 5 years
Incidence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol
Time frame: until 5 years
Titer of ADA
Time frame: until 5 years
Persistence of ADA
Time frame: until 5 years
Prevalence of hypertension, anti-hypertensive regimen, and systolic and diastolic blood pressure
Time frame: until 5 years
Prevalence of dyslipidemia, lipid-lowering regimen, and measures of dyslipidemia, including serum TG and total, non-HDL, LDL, and HDL cholesterol
Time frame: until 5 years
Incidence of chronic allograft nephropathy at 1 year
Time frame: At 1 year
HbA1c levels at 3 months, 1, 2, 3, 4, and 5 years post transplantation in non-diabetic participants at baseline.
Time frame: 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.
Time frame: 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.
Time frame: at 1, 2, 3, 4, 5-year
Framingham cardiovascular risk score at 1 year post transplantation
Time frame: at 1 year
Plan to share: 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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Frexalimab