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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Sanofi
Study ID
NCT07412470
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Kidney Transplant Rejection

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 13, 2026
Status verified
Jun 2026
Primary completion
Aug 15, 2029
Completion
Aug 15, 2033

Study Design

Enrollment
526 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Frexalimab
    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)
  • Active Comparator: Tacrolimus
    Tacrolimus

Primary Outcome Measure

Composite efficacy failure rate (BPAR, graft loss, and death) by 1 year post kidney transplantation [ Time Frame: by 1 year ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIP
Montefiore Medical Center - Moses Campus- Site Number : 8400006The BronxNew York10467

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Montefiore Medical Center - Moses Campus· The Bronx, NY

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