A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation (NCT07412470)
A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (2 items) and avoid the listed exclusions (8 items).
Location: Brigham & Women's Hospital- Site Number : 8400049 — Boston, Massachusetts
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (26 Sites)
Showing the first 25 of 26 sites.
- Brigham & Women's Hospital- Site Number : 8400049 — Boston, Massachusetts
- Montefiore Medical Center - Moses Campus- Site Number : 8400006 — The Bronx, New York
- Investigational Site Number : 0320001 — Corrientes,
- Investigational Site Number : 0360002 — Adelaide, South Australia
- Investigational Site Number : 0360001 — Parkville, Victoria
- Investigational Site Number : 0360003 — Sydney,
- Investigational Site Number : 0560002 — Brussels,
- Investigational Site Number : 1520005 — Santiago, Reg Metropolitana de Santiago
- Investigational Site Number : 1520004 — Santiago, Reg Metropolitana de Santiago
- 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,
- Investigational Site Number : 1560009 — Zhengzhou,
- Investigational Site Number : 2080001 — Aarhus,
- Investigational Site Number : 3760002 — Ramat Gan,
- Clinical Research Facility — Torette, Ancona
- Investigational Site Number : 7240001 — Barcelona, Barcelona [Barcelona]
- Investigational Site Number : 7240007 — Barcelona, Catalunya [Cataluña]
- Investigational Site Number : 7240003 — L'Hospitalet de Llobregat, Catalunya [Cataluña]
- Investigational Site Number : 7240005 — Málaga,
📞 Contact the Study Coordinator
Phone: (800) 633-1610
Email: Contact-US@sanofi.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Kidney Transplant Rejection
- Microbiome and Immunosuppression: The Mission Study — Minneapolis, Minnesota
- Trifecta-Kidney cfDNA-MMDx Study — Tampa, Florida
- Validation of Genomic Immune-phenotyping Profiles to Predict Risk of Kidney Transplant Rejection — Chicago, Illinois
- The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive) — Birmingham, Alabama
- Treatment of Antibody-Mediated Rejection (ABMR) With CarBel — Birmingham, Alabama
- Validation of Donor-Derived Cell-Free DNA (Dd-cfDNA) for Kidney Transplant Monitoring — Los Angeles, California
Explore by condition: All Kidney Transplant Rejection clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.