NCT05669001

A Study of TCD601 in de Novo Renal Transplant Recipients

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)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: ITB-Med LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Renal Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	TCD601	Investigational Product
BIOLOGICAL	belatacept	Study Product
DRUG	ATG	Comparator
DRUG	TAC	Comparator
DRUG	MPA	Immunosuppression Therapy
DRUG	Corticosteroids	Immunosuppression Therapy

Timeline

• Start date: 2023-12-28
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2022-12-30
• Last updated: 2026-01-14

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated drug study