Clinical trial NCT05983770: Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
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
Lead sponsor: Eledon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: eGFR at 12 months
timeFrame: Assessed from date of transplant through Day 364 (Month 12)
Secondary outcomes:
measure: NODAT at 12 months post-transplant
timeFrame: Assessed from date of transplant through Day 364 (Month 12
measure: The proportion of patient and graft survival at 12 months post-transplant
timeFrame: Assessed from date of transplant through Day 364 (Month 12)
measure: BPAR-free patient and graft survival at 12 months post-transplant
timeFrame: The proportion of BPAR-free patient and graft survival at 12 months post-transplant
measure: BPAR at 12 months
timeFrame: Assessed from date of transplant through Day 364 (Month 12)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Orange
country: United States
facility: University of California, Irvine Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Washington
country: United States
facility: Medstar Georgetown University Hospital
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: New Orleans
country: United States
facility: Tulane Medical Center
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospita;
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: New York University Langone Health - Tisch Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center / New York Presbyterian Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Harrisburg
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Health
state: Wisconsin
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Perth
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: São Paulo
country: Brazil
facility: Fundação Oswaldo Ramos - Hospital do Rim
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de São Paulo
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Bois-Guillaume
country: France
facility: Hopital de Bois-Guillaume
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Créteil
country: France
facility: Henri Mondor Hospital
city: Grenoble
country: France
facility: CHU Grenoble-Alpes - Hopital Nord Michallon
city: Limoges
country: France
facility: Centre Hospitalier Universitaire Dupuytren
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital de Rangueil
city: Tours
country: France
facility: CHRU Tours - Hopital Bretonneau
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut Mar
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
Study officials:
References: