Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
- Conditions
- Kidney Transplant Rejection
- Interventions
- Registration Number
- NCT05983770
- Lead Sponsor
- Eledon Pharmaceuticals
- Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
- Detailed Description
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 120
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Investigative AT-1501 AT-1501 monoclonal antibody targeting CD40L given as an IV infusion Comparator Tacrolimus Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter
- Primary Outcome Measures
Name Time Method eGFR at 12 months Assessed from date of transplant through Day 364 (Month 12) Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant
- Secondary Outcome Measures
Name Time Method NODAT at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12 The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant
The proportion of patient and graft survival at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12) Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis
BPAR-free patient and graft survival at 12 months post-transplant The proportion of BPAR-free patient and graft survival at 12 months post-transplant Assessed from date of transplant through Day 364 (Month 12)
BPAR at 12 months Assessed from date of transplant through Day 364 (Month 12) The proportion of BPAR at 12 months
Trial Locations
- Locations (56)
Tulane Medical Center
🇺🇸New Orleans, Louisiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Massachusetts General Hospita;
🇺🇸Boston, Massachusetts, United States
Mount Sinai Medical Center
🇺🇸New York, New York, United States
University of Wisconsin Health
🇺🇸Madison, Wisconsin, United States
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
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 Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Hospital del Mar - Parc de Salut Mar
🇪🇸Barcelona, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
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
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Medstar Georgetown University Hospital
🇺🇸Washington, 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
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Brigham and Women's 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
🇺🇸Saint 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
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Pittsburgh Medical Center
🇺🇸Harrisburg, Pennsylvania, United States
Columbia University Irving Medical Center / New York Presbyterian 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
UT Southwestern
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Hopital de Bois-Guillaume
🇫🇷Bois-Guillaume, France
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Henri Mondor Hospital
🇫🇷Créteil, France