Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

NCT05983770 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: AT-1501-K2072023-503336-41-00U1111-1278-5225
• Study Type: interventional
• Target: 127
• Locations: 7 countries
• Sites: 43

Brief Summary

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

Conditions

Kidney Transplant Rejection

Keywords

AT-1501; Kidney Transplant; Renal Allograft Rejection; Prophylaxis; CD40L Inhibitor; Humanized blocking antibody to CD40L; Monoclonal Antibody; Renal; Transplant; ESRD; Tegoprubart

Outcome Measures

Primary Outcomes (1)

• eGFR at 12 months

  Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant

  Assessed from date of transplant through Day 364 (Month 12)

Secondary Outcomes (4)

• NODAT at 12 months post-transplant

  Assessed from date of transplant through Day 364 (Month 12

• The proportion of patient and graft survival at 12 months post-transplant

  Assessed from date of transplant through Day 364 (Month 12)

• 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

• BPAR at 12 months

  Assessed from date of transplant through Day 364 (Month 12)

Study Arms (2)

Investigative

EXPERIMENTAL

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Drug: AT-1501

Comparator

ACTIVE COMPARATOR

Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter

Drug: Tacrolimus

Interventions

AT-1501 DRUG

IV infusions of AT-1501 20 mg/kg over 1 hour.

Also known as: Tegoprubart

Investigative

Tacrolimus DRUG

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.

Comparator

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• a. Donation after Cardiac Death (DCD) criteria; Or
• b. Kidney Donor Profile Index (KDPI) of \> 85%; Or
• c. 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

Sponsors & Collaborators

• Eledon Pharmaceuticals: lead

Study Sites (43)

University of California Los Angeles

Los Angeles, California, 90024, United States

Location

Keck School of Medicine of USC

Los Angeles, California, 90033, United States

Location

University of California, Irvine Medical Center

Orange, California, 92868, United States

Location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

Location

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Augusta University

Augusta, Georgia, 30912, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Tulane Medical Center

New Orleans, Louisiana, 70112, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospita;

Boston, Massachusetts, 02114, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55907, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

New York University Langone Health - Tisch Hospital

New York, New York, 10016, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Pittsburgh Medical Center

Harrisburg, Pennsylvania, 17104, United States

Location

UT Southwestern

Dallas, Texas, 75235, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

University of Wisconsin Health

Madison, Wisconsin, 53792, United States

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Fiona Stanley Hospital

Perth, Western Australia, 6150, Australia

Location

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo, Brazil

Location

Hospital das Clínicas da Faculdade de Medicina de São Paulo

São Paulo, Brazil

Location

St. Paul's Hospital

Vancouver, British Columbia, Canada

Location

Groupe Hospitalier Pellegrin

Bordeaux, France

Location

CHU Grenoble-Alpes - Hopital Nord Michallon

Grenoble, France

Location

Centre Hospitalier Universitaire Dupuytren

Limoges, 87042, France

Location

CHU de Toulouse - Hopital de Rangueil

Toulouse, France

Location

CHRU Tours - Hopital Bretonneau

Tours, France

Location

Charite Universitatsmedizin Berlin

Berlin, Germany

Location

Hospital del Mar - Parc de Salut Mar

Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Germans Trias i Pujol

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 9, 2023
• Study Start: August 30, 2023
• Primary Completion: September 11, 2025
• Study Completion: September 25, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (27); FR (5); BR (2); AU (2); DE (1); ES (5); CA (1)