A Study of TCD601 in de Novo Renal Transplant Recipients
- Conditions
- Renal Transplantation
- Interventions
- Registration Number
- NCT05669001
- Lead Sponsor
- ITB-Med LLC
- Brief Summary
The purpose of this study is to evaluate the safety and efficacy of TCD601 in combination with Belatacept when compared to standard of care immunosuppression therapy in de novo renal transplant patients.
- Detailed Description
The purpose of this study is to evaluate the safety and efficacy of TCD601 (siplizumab), an anti-CD2 monoclonal antibody, in combination with a CNI-free regimen of belatacept, MPA, and corticosteroids compared to a standard of care CNI-based regimen of tacrolimus, ATG, MPA and corticosteroids in de novo renal transplant patients.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 90
- Able to understand the study requirements and provide written informed consent before and study assessment is performed
- Male or female patients ≥ 18 to 70 years of age
- Recipients of a de novo renal allograft from a heart-beating deceased, living ABO compatable, non-HLA identical living related donor
Key
- Subjects who have received a kidney allograft previously
- Recipient of a kidney from an HLA identical living related donor
- Recipient of a kidney from a donor after cardiac death
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TCD601 (siplizumab) TCD601 TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids TCD601 (siplizumab) belatacept TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids TCD601 (siplizumab) Corticosteroids TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids ATG Corticosteroids Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids ATG TAC Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids TCD601 (siplizumab) MPA TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids ATG ATG Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids ATG MPA Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
- Primary Outcome Measures
Name Time Method The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 12 months The number of adverse events and serious adverse events
- Secondary Outcome Measures
Name Time Method Renal function in Arm 1 compared to Arm 2 12 months renal function using estimated glomerular filtration rate (eGFR)
Trial Locations
- Locations (27)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University in St. Louis (Barnes-Jewish Hospital)
🇺🇸Saint Louis, Missouri, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Weill Cornell Medicine
🇺🇸New York, New York, United States
Atrium Health Wake Forest Baptist Medical Center
🇺🇸Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
UT Health San Antonio
🇺🇸San Antonio, Texas, United States
University of Virginia Health
🇺🇸Charlottesville, Virginia, United States
University of Virginia Hospital
🇺🇸Charlottesville, Virginia, United States
Inova Fairfax Hospital Medical Campus
🇺🇸Falls Church, Virginia, United States