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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.

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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
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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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