Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients
- Registration Number
- NCT06126380
- Lead Sponsor
- Eledon Pharmaceuticals
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 132
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AT-1501 AT-1501 AT-1501 20 mg/kg administered every 3 weeks IV + MMF 1000 mg per os (orally) (PO) twice daily (BID) or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO once daily (QD) or equivalent Tacrolimus Tacrolimus Tacrolimus dosed PO BID with the dose titrated to maintain a trough concentration of 6-8 ng/mL+ MMF 1000 mg PO BID or MPS 720 mg PO BID + Corticosteroids 5 mg of prednisone PO QD or equivalent
- Primary Outcome Measures
Name Time Method Safety and Tolerability - Incidence of Treatment Emergent Adverse Events Assessed from date of enrollment through Month 48 Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (TEAEoSI).
Safety and Tolerability - Kidney Transplant Medication Side Effects Assessed from date of enrollment through Month 48 Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale-59 (MTSOSD) at baseline and 12, 24, 36, and 48 months.
- Secondary Outcome Measures
Name Time Method Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months Assessed from date of enrollment through Month 48 The Proportion of participants with composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months.
The proportion of patient and graft survival at 12, 24, 36, and 48 months Assessed from date of enrollment through Month 48 A participant is considered to have graft functional impairment if they have an eGFR \<60 mL/min/1.73m\^2.
The proportion of participants with Graft function impairment at 12, 24, 36, and 48 months Assessed from date of enrollment through Month 48 A participant is considered to have graft functional impairment if they have an eGFR \<60 mL/min/1.73m\^2.
Proportion of participants with BPAR at 12, 24, 36, and 48 months Assessed from date of enrollment through Month 48 The Proportion of participants with BPAR at 12, 24, 36, and 48 months.
Trial Locations
- Locations (25)
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
CHU Grenoble-Alpes - Hopital Nord Michallon
🇫🇷Grenoble, France
Centre Hospitalier Universitaire Dupuytren
🇫🇷Limoges, France
CHU de Toulouse - Hopital de Rangueil
🇫🇷Toulouse, France
Charite Universitatsmedizin Berlin
🇩🇪Berlin, Germany
Hospital del Mar - Parc de Salut Mar
🇪🇸Barcelona, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clinical de Barcelona
🇪🇸Barcelona, Spain
McGill University Health Care Centre
🇨🇦Montréal, Quebec, Canada
St. Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University in St. Louis
🇺🇸St. Louis, Missouri, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Fundação Oswaldo Ramos - Hospital do Rim
🇧🇷São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de São Paulo
🇧🇷São Paulo, Brazil
Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
🇬🇧Oxford, United Kingdom