Actively Recruiting
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Led by Sanofi · Updated on 2026-04-27
526
Participants Needed
10
Research Sites
387 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled to receive first kidney transplant from a living or deceased donor
- Low to moderate immunological risk
You will not qualify if you...
- Kidney graft from expanded criteria donor or donor after cardiac death
- Positive T or B cell crossmatch, or positive virtual crossmatch at screening
- Receiving kidney graft from HLA-identical living-related donors
- Current or previous solid organ, cell, multi-organ, or paired kidney transplantation
- Primary cause of end-stage kidney disease is idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
- Active or latent TB, HIV, HBV, or HCV infection
- Known genetically predisposed thrombophilia, history of thromboembolic events, or need for long-term anticoagulation therapy
- Severe medical co-morbidities, active infection, or severely limited life expectancy precluding kidney transplant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
Investigational Site Number : 0360003
Sydney, Australia, 2050
Actively Recruiting
2
Investigational Site Number : 1560003
Chengdu, China, 610041
Actively Recruiting
3
Investigational Site Number : 1560017
Nanchang, China, 330006
Actively Recruiting
4
Investigational Site Number : 1560001
Shanghai, China, 200127
Actively Recruiting
5
Investigational Site Number : 1560006
Wuhan, China, 430030
Actively Recruiting
6
Investigational Site Number : 2080001
Aarhus, Denmark, 8200
Actively Recruiting
7
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
8
Investigational Site Number : 7240003
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
Actively Recruiting
9
Investigational Site Number : 7240005
Málaga, Spain, 29010
Actively Recruiting
10
Investigational Site Number : 8260001
Birmingham, England, United Kingdom, B15 2TH
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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