Clinical trial NCT06126380: Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Official title: AT-1501-K209: BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Kidney Transplant Rejection
Keywords: Kidney Transplant
AT-1501
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: 2023-11-13
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Detailed description: This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.

The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.

Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.

Eligibility criteria: Inclusion Criteria:

* Successfully completed qualifying Parent study, where entry into the OLE was offered;
* Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent;
* Agree not to participate in another interventional study while on treatment;
* If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline, through 90 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6.
* If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 90 days after last administration of the study drug and agree to not donate sperm for 90 days after last administration of the study drug.

Exclusion Criteria:

* Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator;
* Met any of the stopping criteria or discontinued study drug in the Parent study;
* Pregnant or breastfeeding.

Primary outcomes:
measure: Safety and Tolerability - Incidence of Treatment Emergent Adverse Events
timeFrame: Assessed from date of enrollment through Month 48
measure: Safety and Tolerability - Kidney Transplant Medication Side Effects
timeFrame: Assessed from date of enrollment through Month 48
Secondary outcomes:
measure: The proportion of patient and graft survival at 12, 24, 36, and 48 months
timeFrame: Assessed from date of enrollment through Month 48
measure: The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months
timeFrame: Assessed from date of enrollment through Month 48
measure: Proportion of participants with BPAR at 12, 24, 36, and 48 months
timeFrame: Assessed from date of enrollment through Month 48
measure: Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months
timeFrame: Assessed from date of enrollment through Month 48
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: Washington
country: United States
facility: MedStar Georgetown University Hospital
state: District of Columbia
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
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: 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: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South 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: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Montréal
country: Canada
facility: McGill University Health Care Centre
state: Quebec
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
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: 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 Clinical de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Study officials:
References: