This study is in progress, not accepting new patients

A Study of TCD601 in de Novo Renal Transplant Recipients

a study on Kidney Transplant

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around

Description

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.

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)

Details

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.

Keywords

Renal Transplantation, siplizumab, Abatacept, Antilymphocyte Serum, Tacrolimus, Mycophenolic Acid, Adrenal Cortex Hormones, TCD601, belatacept, ATG, TAC, MPA, Corticosteroids, TCD601 (siplizumab)

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • 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

  • University of California Davis Medical Center
    Sacramento California 95817 United States
  • University of California San Francisco Medical Center
    San Francisco California 94143 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ITB-Med LLC
ID
NCT05669001
Phase
Phase 2 Kidney Transplant Research Study
Study Type
Interventional
Participants
About 76 people participating
Last Updated