Frexalimab versus tacrolimus to prevent kidney transplant rejection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, randomized, active-comparator Phase 2/3 trial compares subcutaneous frexalimab given for up to approximately five years with standard oral tacrolimus capsules in adults aged 18–70 receiving their first kidney transplant with low-to-moderate immunologic risk. Participants receive randomized treatment alongside standard adjunctive agents such as rabbit anti-thymocyte globulin induction and mycophenolate, and they are followed with about 38 clinic visits over the treatment and follow-up period. Primary outcomes focus on graft rejection rates and long-term safety and tolerability. The protocol excludes high-immunologic-risk transplants, certain primary kidney diseases, active or latent major infections, and significant comorbidities.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of California San Francisco - Parnassus Heights- Site Number : 8400001
  San Francisco, California, United States Recruiting
• Emory University Hospital- Site Number : 8400002
  Atlanta, Georgia, United States Recruiting
• Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010
  Hines, Illinois, United States Recruiting
• University of Kansas Medical Center- Site Number : 8400044
  Kansas City, Kansas, United States Recruiting
• University of Maryland School of Medicine - Baltimore- Site Number : 8400045
  Baltimore, Maryland, United States Recruiting
• Brigham & Women's Hospital- Site Number : 8400049
  Boston, Massachusetts, United States Recruiting

+23 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
• Email: Contact-US@sanofi.com
• Phone: 800-633-1610

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belimumab to mobilize memory B cells to help delistings for highly sensitized kidney transplant candidates

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• Platelet aggregation for diagnosing acute kidney transplant rejection

  This study will test whether changes in platelet activation measured from blood can help detect acute rejection in adult kidney transplant recipients.

  Recruiting University Hospital, Martin · Martin · NCT07275541

• Donor-Derived Cell-Free DNA Test for Monitoring Kidney Transplants

  This test will try whether a blood-based donor-derived cell-free DNA (dd-cfDNA) assay can detect rejection in adults who have received a kidney transplant.

  Recruiting at 6 sites Insight Molecular Diagnostics · Los Angeles, California and 9 other locations · NCT07060716

• CRISPR-edited donor kidney transplant to reduce rejection risk

  This trial will see if donor kidneys edited with CRISPR to turn off key HLA genes can lower rejection in adults with end-stage kidney disease receiving transplants.

  Recruiting Phase 1/2 American Organ Transplant and Cancer Research Institute LLC · Beijing, Changping · NCT07053462

• Tocilizumab plus standard therapy for chronic antibody-mediated rejection after kidney transplant

  This trial will try adding tocilizumab to standard treatment (plasmapheresis, IVIG, and rituximab) to see if it helps people with chronic active antibody-mediated rejection of a kidney transplant.

  Recruiting Shahid Beheshti University of Medical Sciences · Tehran · NCT07006532

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.