Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Full description
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
Currently treated with corticosteroids other than topical or inhaled corticosteroids
Will receive a kidney with an anticipated cold ischemia time of > 30 hours
Will receive a kidney from a donor that meets any of the following:
Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening
Primary purpose
Allocation
Interventional model
Masking
120 participants in 2 patient groups
Loading...
Central trial contact
Eledon Pharmaceuticals
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal