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

Sanofi

Status and phase

Enrolling

Phase 3

Phase 2

Conditions

Kidney Transplant Rejection

Treatments

Drug: Frexalimab

Drug: prednisone

Drug: mycophenolate sodium

Drug: rabbit anti-thymocyte globulin

Drug: Tacrolimus

Drug: methylprednisolone

Drug: mycophenolate mofetil

Study type

Interventional

Funder types

Industry

Identifiers

NCT07412470

2025-521521-33-00 (Registry Identifier)

EFC18554

Details and patient eligibility

About

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.

Enrollment

526 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

526 participants in 2 patient groups

Frexalimab

Experimental group

Description:

Frexalimab: the first dose of frexalimab will be given intravenously, the maintenance dose of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)

Treatment:

Drug: methylprednisolone

Drug: mycophenolate mofetil

Drug: rabbit anti-thymocyte globulin

Drug: Frexalimab

Drug: mycophenolate sodium

Drug: prednisone

Drug: Frexalimab

Tacrolimus

Active Comparator group

Description:

Tacrolimus