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A Study of TCD601 in de Novo Renal Transplant Recipients
Sponsor: ITB-Med LLC
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.
Official title: A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2023-12-28
Completion Date
2026-04
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
TCD601
Investigational Product
belatacept
Study Product
ATG
Comparator
TAC
Comparator
MPA
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
Locations (17)
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
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Atrium Health Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Virginia Health
Charlottesville, Virginia, United States
Inova Fairfax Hospital Medical Campus
Falls Church, Virginia, United States