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

RecruitingPhase 2, Phase 3Ages 18 Years - 70 YearsAllSanofi
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Frexalimab
  • Frexalimab
  • Tacrolimus
  • rabbit anti-thymocyte globulin
  • mycophenolate mofetil
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Where

73 sites
University of California San Francisco - Parnassus Heights- Site Number : 8400001
San Francisco, United States
Emory University Hospital- Site Number : 8400002
Atlanta, United States
Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010
Hines, United States
University of Kansas Medical Center- Site Number : 8400044
Kansas City, United States
University of Maryland School of Medicine - Baltimore- Site Number : 8400045
Baltimore, United States
Brigham & Women's Hospital- Site Number : 8400049
Boston, United States
University of Michigan Health System - Ann Arbor- Site Number : 8400022
Ann Arbor, United States
The Mount Sinai Hospital- Site Number : 8400027
New York, United States

โ€ฆand 65 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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