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NCT05669001 Clinical Trial

A Study of TCD601 in de Novo Renal Transplant Recipients

Renal Transplantation Clinical Trial

— ASCEND  

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)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05669001
Other study ID # TCD601B203
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 28, 2023
Est. completion date October 2026

Study information
Verified date April 2024
Source ITB-Med LLC
Contact Britain Javens, MS
Phone (212) 969-7823
Email britain.javens@itb-med.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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 information / eligibility
Status Recruiting
Enrollment 90
Est. completion date October 2026
Est. primary completion date July 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Key Inclusion Criteria: - 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 Exclusion Criteria: - 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

Related Conditions & MeSH terms

Intervention

Biological:
• TCD601
Investigational Product
• belatacept
Study Product
Drug:
• ATG
Comparator
• TAC
Comparator
• MPA
Immunosuppression Therapy
• Corticosteroids
Immunosuppression Therapy

Locations
Country Name City State
United States Emory University Hospital Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States Montefiore Medical Center Bronx New York
United States Medical University of South Carolina Charleston South Carolina
United States University of Virginia Health Charlottesville Virginia
United States University of Virginia Hospital Charlottesville Virginia
United States Northwestern University Chicago Illinois
United States University of Cincinnati Medical Center Cincinnati Ohio
United States Henry Ford Hospital Detroit Michigan
United States Inova Fairfax Hospital Medical Campus Falls Church Virginia
United States Houston Methodist Hospital Houston Texas
United States University of Kansas Medical Center Kansas City Kansas
United States Scripps Green Hospital La Jolla California
United States University of Southern California Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Mount Sinai Hospital New York New York
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic Rochester Minnesota
United States University of California Davis Medical Center Sacramento California
United States Washington University in St. Louis (Barnes-Jewish Hospital) Saint Louis Missouri
United States UT Health San Antonio San Antonio Texas
United States University of California San Francisco Medical Center San Francisco California
United States Tampa General Hospital Tampa Florida
United States Atrium Health Wake Forest Baptist Medical Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
ITB-Med LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2 The number of adverse events and serious adverse events 12 months
Secondary Renal function in Arm 1 compared to Arm 2 renal function using estimated glomerular filtration rate (eGFR) 12 months
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