A Study of TCD601 in de Novo Renal Transplant Recipients
NCT ID: NCT05669001
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
76 participants
INTERVENTIONAL
2023-12-28
2026-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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TCD601 (siplizumab)
TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids
TCD601
Investigational Product
belatacept
Study Product
MPA
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
ATG
Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids
ATG
Comparator
TAC
Comparator
MPA
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
Interventions
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TCD601
Investigational Product
belatacept
Study Product
ATG
Comparator
TAC
Comparator
MPA
Immunosuppression Therapy
Corticosteroids
Immunosuppression Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Recipient of a kidney from an HLA identical living related donor
* Recipient of a kidney from a donor after cardiac death
18 Years
70 Years
ALL
No
Sponsors
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ITB-Med LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Fredrik Juhlin
Role: STUDY_DIRECTOR
ITB-Med LLC
Locations
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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
Countries
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Other Identifiers
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TCD601B203
Identifier Type: -
Identifier Source: org_study_id
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