At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Frexalimab (drug), Frexalimab (drug), Tacrolimus (drug), rabbit anti-thymocyte globulin (drug)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- Frexalimab — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · Frexalimab — drug: Pharmaceutical form:Solution for injection-Route of administration:SC · Tacrolimus — drug: Pharmaceutical form:Capsule-Route of administration:Oral · rabbit anti-thymocyte globulin — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · mycophenolate mofetil — drug: Pharmaceutical form:Tablet or capsule-Route of administration:Oral · mycophenolate sodium — drug: Pharmaceutical form:Tablet-Route of administration:Oral · methylprednisolone — drug: Pharmaceutical form:Solution for injection-Route of administration:IV · prednisone — drug: Pharmaceutical form:Tablet-Route of administration:Oral
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 70 Years
- Who
- All
- Number of participants
- 526
- Started
- 2026-03-13
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for kidney transplant rejection
- • Phase2/Phase3 - 526 participants
- • 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
Who can take part?
- • Ages 18 Years to 70 Years
- • Diagnosed with kidney transplant rejection
Where?
- • Birmingham - Investigational Site Number : 8260001
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 70 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
- ✓Participants with low to moderate immunological risk.
Who cannot take part
- ✗Deceased donor kidney graft qualified as expanded criteria donor or donor after heart 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...
- ✗Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic...
- ✗Evidence of active or latent TB, HIV, HBV or HCV infection.
See the full criteria
Where Is This Study? (1 UK site)
Investigational Site Number : 8260001
Birmingham B15 2TH, United Kingdom
How to Get in Touch
Trial Transparency email recommended (Toll free for US & Canada)
Sponsor contactCONTACT
