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Completed

NCT Number: NCT05669001

A Study of TCD601 in de Novo Renal Transplant Recipients

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.

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Key information

Conditions

Renal Transplantation

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California Davis Medical Center, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TCD601

Biological

Investigational Product

Other names: siplizumab

Belatacept

Biological

Study Product

ATG

Drug

Comparator

Other names: antithymocyte globulin

TAC

Drug

Comparator

Other names: tacrolimus

MPA

Drug

Immunosuppression Therapy

Other names: mycophenolic acid

Corticosteroids

Drug

Immunosuppression Therapy

Primary outcomes

  1. The incidence of adverse events (AEs) and serious adverse events (SAEs) in Arm 1 compared to Arm 2

    Time frame: 12 months

    The number of adverse events and serious adverse events

Secondary outcomes

  1. Renal function in Arm 1 compared to Arm 2

    Time frame: 12 months

    renal function using estimated glomerular filtration rate (eGFR)

Sponsors and collaborators

Lead sponsor

ITB-Med LLC

Industry

Registry information

Official study 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)

Acronym: ASCEND

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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