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

NCT07412470 · tracked via the Priya Life Science Sweden tracker

Sponsor

Sanofi

Phase

Phase 2/3

Started

2026-03-13

Last updated

2026-09-21

Condition(s) studied

Kidney Transplant Rejection

Investigational drug(s) / intervention(s)

Frexalimab →Frexalimab →Tacrolimus →rabbit anti-thymocyte globulin →mycophenolate mofetil →mycophenolate sodiummethylprednisolone →prednisone →

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 (63)

Facility	City	Region	Status
Emory University Hospital- Site Number : 8400002	Atlanta	Georgia	Recruiting
Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010	Hines	Illinois	Recruiting
University of Kansas Medical Center- Site Number : 8400044	Kansas City	Kansas	Recruiting
University of Maryland School of Medicine - Baltimore- Site Number : 8400045	Baltimore	Maryland	Recruiting
Brigham & Women's Hospital- Site Number : 8400049	Boston	Massachusetts	Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400022	Ann Arbor	Michigan	Recruiting
The Mount Sinai Hospital- Site Number : 8400027	New York	New York	Recruiting
Columbia University Irving Medical Center- Site Number : 8400007	New York	New York	Recruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400006	The Bronx	New York	Recruiting
The Ohio State University- Site Number : 8400025	Columbus	Ohio	Recruiting
University of Washington Medical Center- Site Number : 8400035	Seattle	Washington	Recruiting
Investigational Site Number : 0320002	Buenos Aires	Argentina	Recruiting
Investigational Site Number : 0320001	Corrientes	Argentina	Recruiting
Investigational Site Number : 0360003	Sydney	New South Wales	Recruiting
Investigational Site Number : 0360002	Adelaide	South Australia	Recruiting
Investigational Site Number : 0360004	Clayton	Victoria	Recruiting
Investigational Site Number : 0360001	Parkville	Victoria	Recruiting
Investigational Site Number : 0560002	Brussels	Belgium	Recruiting
Investigational Site Number : 0560001	Leuven	Belgium	Recruiting
Hospital Geral de Fortaleza - HGF- Site Number : 0760007	Fortaleza	Ceará	Recruiting
Irmandade da Santa Casa de Misericórdia de Porto Alegre- Site Number : 0760004	Porto Alegre	Rio Grande do Sul	Recruiting
Hospital do Rim e Hipertensão- Site Number : 0760001	São Paulo	Brazil	Recruiting
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo- Site Number : 0760006	São Paulo	Brazil	Recruiting
Investigational Site Number : 1520005	Santiago	Reg Metropolitana de Santiago	Recruiting
Investigational Site Number : 1520004	Santiago	Reg Metropolitana de Santiago	Recruiting
Investigational Site Number : 1560018	Beijing	China	Recruiting
Investigational Site Number : 1560003	Chengdu	China	Recruiting
Investigational Site Number : 1560007	Guangzhou	China	Recruiting
Investigational Site Number : 1560020	Guangzhou	China	Recruiting
Investigational Site Number : 1560002	Hangzhou	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 : 1560016	Shanghai	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 : 2030002	Ostrava	Czechia	Recruiting

+ 23 more sites — see the full list on the official registry below.

On this site

📄 Deltasone (prednisone) drug profile →

More Sanofi trials in Sweden

A Study to Test an Oral Medicine, Belumosudil, in Combination With Corticosteroids in Participants at Least 12 Years of Age With Newly Diagnosed Chronic Graft Versus Host Disease. Active, not recruiting

A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease Recruiting

A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction Recruiting

A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant Active, not recruiting

International Treatment-extension Study in Adult Participants With Multiple Myeloma and Who Have Derived Clinical Benefit From Isatuximab Enrolling by invitation

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 Sweden