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

NCT07412470 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: EFC185542025-521521-33-00
• Study Type: interventional
• Target: 526
• Locations: 7 countries
• Sites: 16

Brief 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.

Conditions

Kidney Transplant Rejection

Outcome Measures

Primary Outcomes (1)

• 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.

  by 1 year

Secondary Outcomes (30)

• eGFR at 1 year post kidney transplantation

  at 1 year

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

  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

  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

  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

  from Month 3 to 12

Study Arms (2)

Frexalimab

EXPERIMENTAL

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)

Drug: Frexalimab; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone

Tacrolimus

ACTIVE COMPARATOR

Tacrolimus

Drug: Tacrolimus; Drug: rabbit anti-thymocyte globulin; Drug: mycophenolate mofetil; Drug: mycophenolate sodium; Drug: methylprednisolone; Drug: prednisone

Interventions

Frexalimab DRUG

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

Also known as: SAR441344

Frexalimab

Tacrolimus DRUG

Pharmaceutical form:Capsule-Route of administration:Oral

Tacrolimus

rabbit anti-thymocyte globulin DRUG

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

Frexalimab; Tacrolimus

mycophenolate mofetil DRUG

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

Frexalimab; Tacrolimus

mycophenolate sodium DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Frexalimab; Tacrolimus

methylprednisolone DRUG

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

Frexalimab; Tacrolimus

prednisone DRUG

Pharmaceutical form:Tablet-Route of administration:Oral

Frexalimab; Tacrolimus

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
• Participants with low to moderate immunological risk.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (16)

Investigational Site Number : 0360001

Parkville, Victoria, 3050, Australia

RECRUITING

Investigational Site Number : 0360003

Sydney, 2050, Australia

RECRUITING

Investigational Site Number : 1520004

Santiago, Reg Metropolitana de Santiago, 8330034, Chile

RECRUITING

Investigational Site Number : 1560003

Chengdu, 610041, China

RECRUITING

Investigational Site Number : 1560012

Jinan, 250014, China

RECRUITING

Investigational Site Number : 1560017

Nanchang, 330006, China

RECRUITING

Investigational Site Number : 1560008

Nanning, 530007, China

RECRUITING

Investigational Site Number : 1560001

Shanghai, 200127, China

RECRUITING

Investigational Site Number : 1560006

Wuhan, 430030, China

RECRUITING

Investigational Site Number : 2080001

Aarhus, 8200, Denmark

RECRUITING

Investigational Site Number : 3760002

Ramat Gan, 5262100, Israel

RECRUITING

Investigational Site Number : 7240001

Barcelona, Barcelona [Barcelona], 08035, Spain

RECRUITING

Investigational Site Number : 7240007

Barcelona, Catalunya [Cataluña], 08036, Spain

RECRUITING

Investigational Site Number : 7240003

L'Hospitalet de Llobregat, Catalunya [Cataluña], 08907, Spain

RECRUITING

Investigational Site Number : 7240005

Málaga, 29010, Spain

RECRUITING

Investigational Site Number : 8260001

Birmingham, England, B15 2TH, United Kingdom

RECRUITING

Related Links

• EFC18554 Plain Language Results Summary

MeSH Terms

Interventions

Tacrolimus; Antilymphocyte Serum; Mycophenolic Acid; Methylprednisolone; Prednisone

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Pregnadienediols

Central Study Contacts

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

CONTACT

800-633-1610; Contact-US@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: \[Specify Complex Masking\]
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: \[Specify Complex Design\]

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 17, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): August 15, 2029
• Study Completion (Estimated): August 15, 2033
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); DK (1); ES (4); CN (6); AU (2); CL (1); IL (1)