A Study of TCD601 in de Novo Renal Transplant Recipients

Phase 2Active Not RecruitingNCT05669001

ITB-Med LLC76 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Renal Transplantation

Interventions

TCD601BIOLOGICAL

Investigational Product

belataceptBIOLOGICAL

Study Product

ATGDRUG

Comparator

TACDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (17)

University of California Davis Medical Center

Sacramento, California, United States

University of California San Francisco Medical Center

San Francisco, California, United States

Outcomes

Primary Outcomes

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

Time frame: 12 months

Secondary Outcomes

Renal function in Arm 1 compared to Arm 2

renal function using estimated glomerular filtration rate (eGFR)

Time frame: 12 months

Data from ClinicalTrials.gov

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