Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
NCT ID: NCT05983770
Last Updated: 2025-10-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
127 participants
INTERVENTIONAL
2023-08-30
2025-09-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigative
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
Comparator
Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
Tacrolimus
Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
Interventions
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AT-1501
IV infusions of AT-1501 20 mg/kg over 1 hour.
Tacrolimus
Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
No
Sponsors
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Eledon Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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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
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
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Health
Madison, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Fundação Oswaldo Ramos - Hospital do Rim
São Paulo, , Brazil
Hospital das Clínicas da Faculdade de Medicina de São Paulo
São Paulo, , Brazil
St. Paul's Hospital
Vancouver, British Columbia, Canada
Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU Grenoble-Alpes - Hopital Nord Michallon
Grenoble, , France
Centre Hospitalier Universitaire Dupuytren
Limoges, , France
CHU de Toulouse - Hopital de Rangueil
Toulouse, , France
CHRU Tours - Hopital Bretonneau
Tours, , France
Charite Universitatsmedizin Berlin
Berlin, , Germany
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Countries
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Other Identifiers
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2023-503336-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1278-5225
Identifier Type: OTHER
Identifier Source: secondary_id
AT-1501-K207
Identifier Type: -
Identifier Source: org_study_id
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