Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
NCT ID: NCT06126380
Last Updated: 2025-12-10
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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ENROLLING_BY_INVITATION
PHASE2
132 participants
INTERVENTIONAL
2023-10-25
2029-12-31
Brief Summary
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Detailed Description
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The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.
Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AT-1501
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
AT-1501
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
Tacrolimus
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
Tacrolimus
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
Interventions
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AT-1501
AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg PO twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent
Tacrolimus
Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Met any of the stopping criteria or discontinued study drug in the Parent study;
* Pregnant or breastfeeding.
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
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
Virginia Commonwealth University
Richmond, Virginia, 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
McGill University Health Care Centre
Montreal, Quebec, 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
Charite Universitatsmedizin Berlin
Berlin, , Germany
Hospital del Mar - Parc de Salut Mar
Barcelona, , Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Clinical de Barcelona
Barcelona, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
Hospital Germans Trias i Pujol
Barcelona, , Spain
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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EU CTR
Identifier Type: OTHER
Identifier Source: secondary_id
UTN
Identifier Type: OTHER
Identifier Source: secondary_id
AT-1501-K209
Identifier Type: -
Identifier Source: org_study_id
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