Actively Recruiting
A Seamless Phase 2/3 Randomized, Open-label Study to Investigate Efficacy and Safety of Frexalimab Versus Tacrolimus in Adult Kidney Transplant Recipients
Led by Sanofi · Updated on 2026-06-05
526
Participants Needed
23
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of frexalimab compared to tacrolimus in adults aged 18 to 70 years who are undergoing their first kidney transplant and have a low to moderate risk of graft rejection. This study is an open-label, randomized trial sponsored by Sanofi, designed as a seamless Phase 2/3 trial. The goal is to assess treatment outcomes over a period of up to five years. Participants are randomly assigned to receive either frexalimab or tacrolimus. Frexalimab treatment starts with an intravenous dose followed by maintenance doses given subcutaneously via an on-body delivery system. The study lasts up to about five years with approximately 38 visits planned. Tacrolimus is administered orally as capsules. The study also includes other immunosuppressive drugs as part of the treatment regimen. During the trial, participants will have regular assessments including kidney function tests (eGFR), proteinuria measurements, monitoring for graft rejection and survival, and evaluation of side effects related to immunosuppressive therapy. Researchers will also track antibody development, blood pressure, cholesterol levels, and occurrence of new diabetes. Safety monitoring will continue throughout the five-year period to evaluate overall participant and graft outcomes.
CONDITIONS
Brief 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...
- Adults aged 18 to 70 years
- Scheduled to receive their first kidney transplant from a living or deceased donor
- Low to moderate immunological risk for graft rejection
You will not qualify if you...
- Kidney graft from an expanded criteria donor or donor after cardiac death
- Positive T or B cell crossmatch or positive virtual crossmatch at screening
- Receiving kidney 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 tuberculosis, HIV, hepatitis B, or hepatitis C infection
- Known genetic thrombophilia, history of thromboembolic events, or need for long-term anticoagulation
- Severe medical co-morbidities, active infection, or limited life expectancy precluding kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year post kidney transplantation
Participants receive kidney transplantation followed by immunosuppressive drug treatment with either Frexalimab or Tacrolimus to prevent graft rejection.
Regular visits for treatment administration and monitoring as per protocol
Duration - Up to 5 years post kidney transplantation
Participants are monitored for efficacy and safety outcomes including kidney function, graft survival, and adverse events for up to 5 years after transplantation.
Periodic visits for assessments at 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years
Trial Site Locations
Total: 23 locations
1
Montefiore Medical Center - Moses Campus- Site Number : 8400006
The Bronx, New York, United States, 10467
Actively Recruiting
2
Investigational Site Number : 0320001
Corrientes, Argentina, 3400
Actively Recruiting
3
Investigational Site Number : 0360002
Adelaide, South Australia, Australia, 5000
Actively Recruiting
4
Investigational Site Number : 0360001
Parkville, Victoria, Australia, 3050
Actively Recruiting
5
Investigational Site Number : 0360003
Sydney, Australia, 2050
Actively Recruiting
6
Investigational Site Number : 1520005
Santiago, Reg Metropolitana de Santiago, Chile, 8320325
Actively Recruiting
7
Investigational Site Number : 1520004
Santiago, Reg Metropolitana de Santiago, Chile, 8330034
Actively Recruiting
8
Investigational Site Number : 1560003
Chengdu, China, 610041
Actively Recruiting
9
Investigational Site Number : 1560012
Jinan, China, 250014
Actively Recruiting
10
Investigational Site Number : 1560017
Nanchang, China, 330006
Actively Recruiting
11
Investigational Site Number : 1560008
Nanning, China, 530007
Actively Recruiting
12
Investigational Site Number : 1560001
Shanghai, China, 200127
Actively Recruiting
13
Investigational Site Number : 1560006
Wuhan, China, 430030
Actively Recruiting
14
Investigational Site Number : 1560005
Zhengzhou, China, 450052
Actively Recruiting
15
Investigational Site Number : 1560009
Zhengzhou, China, 450061
Actively Recruiting
16
Investigational Site Number : 2080001
Aarhus, Denmark, 8200
Actively Recruiting
17
Investigational Site Number : 3760002
Ramat Gan, Israel, 5262100
Actively Recruiting
18
Torette, Ancona, Italy, 60020
Actively Recruiting
19
Investigational Site Number : 7240001
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
20
Investigational Site Number : 7240007
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
21
Investigational Site Number : 7240003
L'Hospitalet de Llobregat, Catalunya [Cataluña], Spain, 08907
Actively Recruiting
22
Investigational Site Number : 7240005
Málaga, Spain, 29010
Actively Recruiting
23
Investigational Site Number : 8260001
Birmingham, England, United Kingdom, B15 2TH
Actively Recruiting
Research Team
T
Trial Transparency email recommended (Toll free for US & Canada)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here