This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
127
IV infusions of AT-1501 20 mg/kg over 1 hour.
Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
eGFR at 12 months
Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
Time frame: Assessed from date of transplant through Day 364 (Month 12)
NODAT at 12 months post-transplant
The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
Time frame: Assessed from date of transplant through Day 364 (Month 12
The proportion of patient and graft survival at 12 months post-transplant
Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
Time frame: Assessed from date of transplant through Day 364 (Month 12)
BPAR-free patient and graft survival at 12 months post-transplant
Assessed from date of transplant through Day 364 (Month 12)
Time frame: The proportion of BPAR-free patient and graft survival at 12 months post-transplant
BPAR at 12 months
The proportion of BPAR at 12 months
Time frame: Assessed from date of transplant through Day 364 (Month 12)
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