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

NCT07412470 · tracked via the Priya Life Science USA tracker

Sponsor

Sanofi

Phase

Phase 2/3

Started

2026-03-13

Last updated

2026-06-23

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

FrexalimabFrexalimabTacrolimusrabbit anti-thymocyte globulinmycophenolate mofetilmycophenolate sodiummethylprednisoloneprednisone

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

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

Tacrolimus: Pharmaceutical form:Capsule-Route of administration:Oral

rabbit anti-thymocyte globulin: Pharmaceutical form:Solution for injection-Route of administration:IV

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

mycophenolate sodium: Pharmaceutical form:Tablet-Route of administration:Oral

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

prednisone: Pharmaceutical form:Tablet-Route of administration:Oral

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (26)

Facility	City	Region	Status
Brigham & Women's Hospital- Site Number : 8400049	Boston	Massachusetts	Recruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400006	The Bronx	New York	Recruiting
Investigational Site Number : 0320001	Corrientes	Argentina	Recruiting
Investigational Site Number : 0360002	Adelaide	South Australia	Recruiting
Investigational Site Number : 0360001	Parkville	Victoria	Recruiting
Investigational Site Number : 0360003	Sydney	Australia	Recruiting
Investigational Site Number : 0560002	Brussels	Belgium	Recruiting
Investigational Site Number : 1520005	Santiago	Reg Metropolitana de Santiago	Recruiting
Investigational Site Number : 1520004	Santiago	Reg Metropolitana de Santiago	Recruiting
Investigational Site Number : 1560003	Chengdu	China	Recruiting
Investigational Site Number : 1560012	Jinan	China	Recruiting
Investigational Site Number : 1560017	Nanchang	China	Recruiting
Investigational Site Number : 1560008	Nanning	China	Recruiting
Investigational Site Number : 1560001	Shanghai	China	Recruiting
Investigational Site Number : 1560011	Tianjin	China	Recruiting
Investigational Site Number : 1560006	Wuhan	China	Recruiting
Investigational Site Number : 1560005	Zhengzhou	China	Recruiting
Investigational Site Number : 1560009	Zhengzhou	China	Recruiting
Investigational Site Number : 2080001	Aarhus	Denmark	Recruiting
Investigational Site Number : 3760002	Ramat Gan	Israel	Recruiting
—	Torette	Ancona	Recruiting
Investigational Site Number : 7240001	Barcelona	Barcelona [Barcelona]	Recruiting
Investigational Site Number : 7240007	Barcelona	Catalunya [Cataluña]	Recruiting
Investigational Site Number : 7240003	L'Hospitalet de Llobregat	Catalunya [Cataluña]	Recruiting
Investigational Site Number : 7240005	Málaga	Spain	Recruiting
Investigational Site Number : 8260001	Birmingham	England	Recruiting

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Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection Active, not recruiting

Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07412470 on ClinicalTrials.gov ↗ ← All trials in the USA