Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Kidney Transplant Rejection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05983770
• Other study ID #: AT-1501-K207
• Secondary ID: 2023-503336-41-0
• Status: Recruiting
• Phase: Phase 2
• Start date: August 30, 2023
• Est. completion date: March 2025

Study information

• Verified date: April 2024
• Source: Eledon Pharmaceuticals
• Contact: Eledon Pharmaceuticals
• Phone: 949-238-8090
• Email: clinicaltrials[@]eledon.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Rejection

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Fiona Stanley Hospital	Perth	Western Australia
Brazil	Fundação Oswaldo Ramos - Hospital do Rim	São Paulo
Brazil	Hospital das Clínicas da Faculdade de Medicina de São Paulo	São Paulo
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
France	Hopital de Bois-Guillaume	Bois-Guillaume
France	Groupe Hospitalier Pellegrin	Bordeaux
France	Henri Mondor Hospital	Créteil
France	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
Germany	Charite Universitatsmedizin Berlin	Berlin
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	Hospital Universitari Vall d'Hebron	Barcelona
United States	Emory University Hospital	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University of Colorado Hospital	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospita;	Boston	Massachusetts
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	UT Southwestern	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Pittsburgh Medical Center	Harrisburg	Pennsylvania
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Keck School of Medicine of USC	Los Angeles	California
United States	University of California Los Angeles	Los Angeles	California
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin Health	Madison	Wisconsin
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Columbia University Irving Medical Center / New York Presbyterian Hospital	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	New York University Langone Health - Tisch Hospital	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	University of California, Irvine Medical Center	Orange	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California, Davis Medical Center	Sacramento	California
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Tampa General Hospital	Tampa	Florida
United States	Medstar Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Eledon Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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
Secondary	BPAR at 12 months	The proportion of BPAR at 12 months	Assessed from date of transplant through Day 364 (Month 12)