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A study to investigate the efficacy and safety of frexalimab versus tacrolimus in adults undergoing kidney transplantation
EU CTIS ID: 2025-521521-33-00
What this study is testing
To demonstrate noninferiority of frexalimab as compared to tacrolimus in preventing kidney graft rejection
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
- Participants with low to moderate immunological risk.
You likely can't join if
- Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac 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 organ, cell, or multi-organ transplantation, or paired kidney transplantation.
- Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
- Evidence of active or latent TB, HIV, HBV or HCV infection.
- Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
See the full eligibility criteria
- Participants who are scheduled to receive their first kidney transplant from a living or deceased donor.
- Participants with low to moderate immunological risk.
- Deceased donor kidney graft qualified as expanded criteria donor or donor after cardiac 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 organ, cell, or multi-organ transplantation, or paired kidney transplantation.
- Participants whose primary causes of ESKD are idiopathic FSGS, C3 glomerulopathy, lupus nephritis, or thrombotic microangiopathy
- Evidence of active or latent TB, HIV, HBV or HCV infection.
- Participants who have known genetically predisposed thrombophilia, have history of thromboembolic events, or who need long-term anti-coagulation therapy.
- Participants who have severe medical co-morbidities, active infection, or severely limited life expectancy due to underlying medical conditions that are generally precluded from kidney transplant.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Canada
- Israel
- United Kingdom
- United States
- Australia
- Japan
- Argentina
- Chile
- Brazil
- Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Canada; Israel; United Kingdom; United States; Australia and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.