This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation. The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study. Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Time frame: Assessed from date of enrollment through Month 48
Safety and Tolerability - Kidney Transplant Medication Side Effects
Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
Time frame: Assessed from date of enrollment through Month 48
The proportion of patient and graft survival at 12, 24, 36, and 48 months
A participant is considered to have graft functional impairment if they have an eGFR \<60 mL/min/1.73m\^2.
Time frame: Assessed from date of enrollment through Month 48
The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months
A participant is considered to have graft functional impairment if they have an eGFR \<60 mL/min/1.73m\^2.
Time frame: Assessed from date of enrollment through Month 48
Proportion of participants with BPAR at 12, 24, 36, and 48 months
The Proportion of participants with BPAR at 12, 24, 36, and 48 months.
Time frame: Assessed from date of enrollment through Month 48
Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months.
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University of California Los Angeles
Los Angeles, California, United States
Keck School of Medicine of USC
Los Angeles, California, United States
University of California, Irvine Medical Center
Orange, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Jacobs Medical Center at UC San Diego Health
San Diego, California, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Tampa General Hospital
Tampa, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
...and 33 more locations
Time frame: Assessed from date of enrollment through Month 48