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: Review the eligibility criteria below.
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 ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 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
- 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
- PROACT Pilot Trial — Vancouver, British Columbia
- AIIM Trial: Personalized Medicine Approach to Kidney Allograft Function — Gainesville, Florida
- Trifecta-Kidney cfDNA-MMDx Study — Tampa, Florida
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.