Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

AT-1501-K207: BESTOW: A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

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

Study Overview

• Status: Completed
• Conditions: Kidney Transplant Rejection
• Intervention / Treatment: Drug: AT-1501; Drug: Tacrolimus

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.

• Study Type: Interventional
• Enrollment (Actual): 127
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Royal Adelaide Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Brazil
  • São Paulo, Brazil
    • Fundação Oswaldo Ramos - Hospital do Rim
  • São Paulo, Brazil
    • Hospital das Clinicas da Faculdade de Medicina de Sao Paulo
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
• France
  • Bordeaux, France
    • Groupe Hospitalier Pellegrin
  • Grenoble, France
    • CHU Grenoble-Alpes - Hopital Nord Michallon
  • Limoges, France, 87042
    • Centre Hospitalier Universitaire Dupuytren
  • Toulouse, France
    • CHU de Toulouse - Hôpital de Rangueil
  • Tours, France
    • CHRU Tours - Hôpital Bretonneau
• Germany
  • Berlin, Germany
    • Charité Universitätsmedizin Berlin
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
  • Barcelona, Spain
    • Hospital Germans Trias i Pujol
  • Barcelona, Spain, 08003
    • Hospital del Mar - Parc de Salut Mar
• United States
  • California
    • Los Angeles, California, United States, 90024
      • University of California Los Angeles
    • Los Angeles, California, United States, 90033
      • Keck School of Medicine of USC
    • Orange, California, United States, 92868
      • University of California, Irvine Medical Center
    • Sacramento, California, United States, 95817
      • University of California, Davis Medical Center
  • District of Columbia
    • Washington D.C., District of Columbia, United States, 20007
      • MedStar Georgetown University Hospital
  • Florida
    • Tampa, Florida, United States, 33606
      • Tampa General Hospital
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Augusta, Georgia, United States, 30912
      • Augusta University
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospita;
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University Of Minnesota Medical Center
    • Rochester, Minnesota, United States, 55907
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University in St. Louis
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Health - Tisch Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17104
      • University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75235
      • UT Southwestern
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington Medical Center
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigative; AT-1501 monoclonal antibody targeting CD40L given as an IV infusion	Drug: AT-1501; IV infusions of AT-1501 20 mg/kg over 1 hour.; Other Names: Tegoprubart
Active Comparator: 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
NODAT at 12 months post-transplant	The proportion of new onset diabetes after transplant (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	Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis	Assessed from date of transplant through Day 364 (Month 12)
BPAR-free patient and graft survival at 12 months post-transplant	Assessed from date of transplant through Day 364 (Month 12)	The proportion of BPAR-free patient and graft survival at 12 months post-transplant
BPAR at 12 months	The proportion of BPAR at 12 months	Assessed from date of transplant through Day 364 (Month 12)

Collaborators and Investigators

• Sponsor: Eledon Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Actual): September 11, 2025
• Study Completion (Actual): September 25, 2025

Study Registration Dates

• First Submitted: August 2, 2023
• First Submitted That Met QC Criteria: August 2, 2023
• First Posted (Actual): August 9, 2023

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: ESRD; Transplant; Monoclonal Antibody; Prophylaxis; Kidney Transplant; Renal; AT-1501; Renal Allograft Rejection; Humanized blocking antibody to CD40L; CD40L Inhibitor; Tegoprubart
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Kidney Failure, Chronic; Organic Chemicals; Macrolides; Lactones; Tacrolimus
• Other Study ID Numbers: AT-1501-K207; 2023-503336-41-00 (Other Identifier: European Clinical Trial Register); U1111-1278-5225 (Other Identifier: World Health Organization)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No