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

ClinicalTrials.gov ID: NCT07412470

Public ClinicalTrials.gov record NCT07412470. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 24, 2026, 7:30 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07412470
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2, Phase 3
Lead sponsor: Sanofi; Industry
Enrollment: 526 participants

Conditions and interventions

Conditions

Kidney Transplant Rejection

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 70 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 13, 2026 (Actual)
Primary completion: Aug 15, 2029 (Estimated)
Completion: Aug 15, 2033 (Estimated)
Last update posted: Oct 13, 2026

2026 – 2033

United States locations

U.S. sites: 14
U.S. states: 11
U.S. cities: 12

Facility	City	State	ZIP	Site status
University of California San Francisco - Parnassus Heights- Site Number : 8400001	San Francisco	California	94143	Recruiting
Emory University Hospital- Site Number : 8400002	Atlanta	Georgia	30324	Recruiting
Edward Hines, Jr. Veterans Affairs Hospital- Site Number : 8400010	Hines	Illinois	60141	Recruiting
University of Kansas Medical Center- Site Number : 8400044	Kansas City	Kansas	66160	Recruiting
University of Maryland School of Medicine - Baltimore- Site Number : 8400045	Baltimore	Maryland	21201	Recruiting
Brigham & Women's Hospital- Site Number : 8400049	Boston	Massachusetts	02115	Recruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400022	Ann Arbor	Michigan	48109	Recruiting
The Mount Sinai Hospital- Site Number : 8400027	New York	New York	10029	Recruiting
Columbia University Irving Medical Center- Site Number : 8400007	New York	New York	10032	Recruiting
Weill Cornell Medical College- Site Number : 8400005	New York	New York	10065	Recruiting
Montefiore Medical Center - Moses Campus- Site Number : 8400006	The Bronx	New York	10467	Recruiting
The Ohio State University- Site Number : 8400025	Columbus	Ohio	43210	Recruiting
VCU Massey Cancer Center: Dalton Oncology Clinic- Site Number : 8400004	Richmond	Virginia	23298	Recruiting
University of Washington Medical Center- Site Number : 8400035	Seattle	Washington	98195	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 59 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07412470, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Oct 13, 2026 · Synced Oct 24, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07412470 live on ClinicalTrials.gov.

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