Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
- Conditions
- Kidney Transplant Rejection
- Interventions
- Registration Number
- NCT05983770
- Lead Sponsor
- Eledon Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
- Detailed 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Male or female ≥ 18 years of age
- Recipient of their first kidney transplant from a living or deceased donor
- Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug
-
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:
- 5a. Donation after Cardiac Death (DCD) criteria; Or
- 5b. Kidney Donor Profile Index (KDPI) of > 85%; Or
- 5c. Is blood group (ABO) incompatible
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigative AT-1501 AT-1501 monoclonal antibody targeting CD40L given as an IV infusion Comparator Tacrolimus Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
- Primary Outcome Measures
Name Time Method eGFR at 12 months Assessed from date of transplant through Day 364 (Month 12) Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
- Secondary Outcome Measures
Name Time Method NODAT at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12 The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
The proportion of patient and graft survival at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12) Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
BPAR-free patient and graft survival at 12 months post-transplant The proportion of BPAR-free patient and graft survival at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12)
BPAR at 12 months Assessed from date of transplant through Day 364 (Month 12) The proportion of BPAR at 12 months
Trial Locations
- Locations (56)
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
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Medstar Georgetown University Hospital
🇺🇸Washington, 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
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