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NCT Number: NCT07412470

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

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.

Recruiting

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Key information

Conditions

Kidney Transplant Rejection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Investigational Site Number : 0320001, Corrientes, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frexalimab

Drug

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

Other names: SAR441344

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

Primary outcomes

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

    Time frame: by 1 year

    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.

Secondary outcomes

  1. eGFR at 1 year post kidney transplantation

    Time frame: at 1 year

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

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

    Time frame: at 6 months, 2 years, 3 years, 4 years, and 5 years

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

  3. 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

  4. 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

  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

    Time frame: from Month 3 to 12

  6. Proteinuria 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

    defined as protein concentration in the urine

  7. iBox score at 1 year post kidney transplantation

    Time frame: at 1 year

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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: up to 5 years

  13. Time to first BPAR

    Time frame: 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

    Time frame: 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

    Time frame: up to 5 years

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

    Time frame: by 6 months

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

    Time frame: at 1 year

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

    Time frame: 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

    Time frame: until 5 years

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

    Time frame: 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

    Time frame: 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

    Time frame: up to 1 year

  23. Incidence of ADA

    Time frame: until 5 years

  24. Incidence of new-onset diabetes post kidney transplantation

    Time frame: until 5 years

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

    Time frame: 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

    Time frame: until 5 years

  27. Titer of ADA

    Time frame: until 5 years

  28. Persistence of ADA

    Time frame: until 5 years

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

    Time frame: 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

    Time frame: until 5 years

  31. Incidence of chronic allograft nephropathy at 1 year

    Time frame: At 1 year

  32. 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

  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.

    Time frame: 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.

    Time frame: at 1, 2, 3, 4, 5-year

  35. Framingham cardiovascular risk score at 1 year post transplantation

    Time frame: at 1 year

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Acronym: FREXERA

Important dates

Study start
2026
Primary completion
2029
Study completion
2033
First posted
Feb 17, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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