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Compares treatment options for Kidney Transplant Rejection
Official title A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
ClinicalTrials.gov ID: NCT07412470
What this study is testing
What is Frexalimab?
Frexalimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for kidney transplant rejection.
Also referred to as SAR441344.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
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...
- 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...
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 above information...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- The Bronx, New York, United States
- Corrientes, Argentina
- Adelaide, South Australia, Australia
- Parkville, Victoria, Australia
- Sydney, Australia
- Brussels, Belgium
- Santiago, Reg Metropolitana de Santiago, Chile
- Chengdu, China
- Jinan, China
- Nanchang, China
- Nanning, China
- Shanghai, China
- Tianjin, China
- Wuhan, China
- Zhengzhou, China
- Aarhus, Denmark
- Ramat Gan, Israel
- Torette, Ancona, Italy
- Barcelona, Barcelona [Barcelona], Spain
+ 4 more site(s).
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 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; The Bronx, New York, United States; Corrientes, Argentina; Adelaide, South Australia, Australia; Parkville, Victoria, Australia; Sydney, Australia and 18 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 ClinicalTrials.gov; the study team decides eligibility.