Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Enrolling by invitation · Phase 2

Conditions studied: Kidney Transplant Rejection

In brief

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

Key facts

Study ID

NCT06126380

Run by

Eledon Pharmaceuticals

People needed

132

Starts

2023-10-25

Expected to finish

2029-12-01

Last updated by the study team

2025-12-10

Who can join

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

You may qualify if…

• Successfully completed qualifying Parent study, where entry into the OLE was offered;
• Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
• Agree not to participate in another interventional study while on treatment;
• If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
• If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.

You may not qualify if…

• Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
• Met any of the stopping criteria or discontinued study drug in the Parent study;
• Pregnant or breastfeeding.

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
• 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
• 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
• John Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — 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

Full record on ClinicalTrials.gov

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