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Recruiting NCT07412470

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

Phase II / Phase III Interventional Kidney Transplant Rejection

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Frexalimab, Frexalimab, Tacrolimus, rabbit anti-thymocyte globulin.
Who it may be relevant to
Registry conditions: Kidney Transplant Rejection. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Argentina, Australia, Belgium, Chile +6
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Frexalimab
    Pharmaceutical form:Solution for injection-Route of administration:IV
  • Drug Frexalimab
    Pharmaceutical form:Solution for injection-Route of administration:SC
  • Drug Tacrolimus
    Pharmaceutical form:Capsule-Route of administration:Oral
  • Drug rabbit anti-thymocyte globulin
    Pharmaceutical form:Solution for injection-Route of administration:IV
  • Drug mycophenolate mofetil
    Pharmaceutical form:Tablet or capsule-Route of administration:Oral
  • Drug mycophenolate sodium
    Pharmaceutical form:Tablet-Route of administration:Oral
  • Drug methylprednisolone
    Pharmaceutical form:Solution for injection-Route of administration:IV
  • Drug prednisone
    Pharmaceutical form:Tablet-Route of administration:Oral

Primary outcome measures

  • Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation [Time frame: by 1 year]
Secondary outcome measures (12)
  • eGFR at 1 year post kidney transplantation [Time frame: at 1 year]
  • 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]
  • 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]
  • 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]
  • 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]
  • 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]
  • iBox score at 1 year post kidney transplantation [Time frame: at 1 year]
  • Composite of participant and graft survival at 5 years post kidney transplantation [Time frame: at 5 years]
  • 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]
  • 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]
  • 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]
  • Incidence of BPAR (yearly and cumulative) up to 5 years post kidney transplantation [Time frame: up to 5 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 9 centers
  • Investigational Site Number : 1560003 — Chengdu
  • Investigational Site Number : 1560012 — Jinan
  • Investigational Site Number : 1560017 — Nanchang
  • Investigational Site Number : 1560008 — Nanning
  • Investigational Site Number : 1560001 — Shanghai
  • Investigational Site Number : 1560011 — Tianjin
  • Investigational Site Number : 1560006 — Wuhan
  • Investigational Site Number : 1560005 — Zhengzhou
  • … and 1 more center
Spain · 4 centers
  • Investigational Site Number : 7240001 — Barcelona
  • Investigational Site Number : 7240007 — Barcelona
  • Investigational Site Number : 7240003 — L'Hospitalet de Llobregat
  • Investigational Site Number : 7240005 — Málaga
Australia · 3 centers
  • Investigational Site Number : 0360002 — Adelaide
  • Investigational Site Number : 0360001 — Parkville
  • Investigational Site Number : 0360003 — Sydney
United States · 2 centers
  • Brigham & Women's Hospital- Site Number : 8400049 — Boston
  • Montefiore Medical Center - Moses Campus- Site Number : 8400006 — The Bronx
Chile · 2 centers
  • Investigational Site Number : 1520005 — Santiago
  • Investigational Site Number : 1520004 — Santiago
Argentina · 1 center
  • Investigational Site Number : 0320001 — Corrientes
Belgium · 1 center
  • Investigational Site Number : 0560002 — Brussels
Denmark · 1 center
  • Investigational Site Number : 2080001 — Aarhus
Israel · 1 center
  • Investigational Site Number : 3760002 — Ramat Gan
Italy · 1 center
  • Center not named — Torette
United Kingdom · 1 center
  • Investigational Site Number : 8260001 — Birmingham

Identifiers

NCT: NCT07412470 · EFC18554 · 2025-521521-33-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗