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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
[Specify Complex Design]
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
[Specify Complex Masking]

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Frexalimab 		The first dose of frexalimab will be given intravenously and subsequent doses of frexalimab will be administered subcutaneously via on-body delivery system(OBDS)
  • Drug: Frexalimab
    Pharmaceutical form:Solution for injection-Route of administration:IV
    Other names:
    • SAR441344
  • Drug: Frexalimab
    Pharmaceutical form:Solution for injection-Route of administration:SC
    Other names:
    • SAR441344
  • 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
Active Comparator
Tacrolimus 		Tacrolimus
  • 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

Recruiting Locations

Brigham & Women's Hospital- Site Number : 8400049
Boston, Massachusetts 02115

Montefiore Medical Center - Moses Campus- Site Number : 8400006
The Bronx, New York 10467

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.