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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

CompletedPhase 2

Sponsor: Eledon Pharmaceuticals

Conditions: Kidney Transplant Rejection

Interventions: AT-1501, Tacrolimus

Countries: United States, Australia, Brazil, Canada, France, Germany, Spain

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

Eligibility overview

Sex: ALL

Age: 18 Years to 100 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Locations (43)

Los Angeles, California, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
Washington D.C., District of Columbia, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Maywood, Illinois, United States
Kansas City, Kansas, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
New York, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Harrisburg, Pennsylvania, United States
Dallas, Texas, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Madison, Wisconsin, United States
Adelaide, South Australia, Australia
Perth, Western Australia, Australia
São Paulo, Brazil
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