Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Completed · Phase 2

Conditions studied: Kidney Transplant Rejection

In brief

This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.

Key facts

Study ID

NCT05983770

Run by

Eledon Pharmaceuticals

People needed

127

Starts

2023-08-30

Expected to finish

2025-09-25

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• 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
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospita; — Boston, Massachusetts, United States
• Henry Ford Health System — Detroit, Michigan, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• New York University Langone Health - Tisch Hospital — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States
• University of Pittsburgh Medical Center — Harrisburg, Pennsylvania, United States
• UT Southwestern — Dallas, Texas, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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