A Study of TCD601 in de Novo Renal Transplant Recipients (ASCEND)

ITBMed

Status and phase: Active, not recruiting; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: TAC; Drug: Corticosteroids; Drug: ATG; Biological: belatacept; Drug: MPA; Biological: TCD601

Study type: Interventional

Funder types: Industry

Identifiers

NCT05669001

TCD601B203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

TCD601 (siplizumab)

Experimental group

Description:

TCD601 administered in combination with belatacept, mycophenolic Acid (MPA), and corticosteroids

Treatment:

Biological: TCD601

Drug: MPA

Biological: belatacept

Drug: Corticosteroids

ATG

Active Comparator group

Description:

Antithymocyte globulin (ATG), tacrolimus (TAC), mycophenolic acid (MPA), and corticosteroids

Treatment:

Drug: MPA

Drug: ATG

Drug: Corticosteroids

Drug: TAC