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ACTIVE NOT RECRUITING
NCT05669001
PHASE2

A Study of TCD601 in de Novo Renal Transplant Recipients

Sponsor: ITB-Med LLC

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

TCD601

Investigational Product

BIOLOGICAL

belatacept

Study Product

DRUG

ATG

Comparator

DRUG

TAC

Comparator

DRUG

MPA

Immunosuppression Therapy

DRUG

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