This study will evaluate the efficacy and safety of tegoprubart compared with tacrolimus in adult participants undergoing first kidney transplantation.
This is a multicenter, randomized, active-controlled, open-label study to assess the efficacy and safety of tegoprubart compared with tacrolimus as part of an immunosuppressive regimen in adult participants undergoing first kidney transplantation. Dose regimens will include either tegoprubart (AT-1501) or tacrolimus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
620
Tegoprubart administered via IV infusion
Tacrolimus administered orally
Efficacy failure rate at 12 months post-transplant, defined as the first occurrence of biopsy proven acute rejection, graft loss, or death
Time frame: 12 months post-transplant
Proportion of participants with for-cause biopsy proven acute rejection, graft loss, or death
Time frame: 12 months post-transplant
Participant and graft survival
Time frame: 12 months post-transplant
Composite risk-prediction score for kidney allograft survival
Time frame: 12 months post-transplant
Mean Renal graft function as assessed by estimated glomerular filtration rate
Time frame: 12 months post-transplant
Incidence of new-onset diabetes after transplantation
Time frame: 12 months post-transplant
Incidence of new or worsening hypertension
Time frame: 12 months post-transplant
Incidence of new or worsening hyperlipidemia
Time frame: 12 months post-transplant
Proportion of participants experiencing deterioration on Patient Reported Outcomes
Time frame: 12 months post-transplant
Incidence of delayed graft function
Time frame: Initial post-transplant period
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