Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion 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, Mycophenolic Acid, Abatacept, Tacrolimus, Antilymphocyte Serum, 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

  • UCSF Medical Center not yet accepting patients
    San Francisco California 94143 United States
  • University of California Davis Medical Center not yet accepting patients
    Sacramento California 95817 United States
  • University of Nebraska Medical Center accepting new patients
    Omaha Nebraska 68198 United States
  • University of Kansas Medical Center accepting new patients
    Kansas City Kansas 66160 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
ITB-Med LLC
ID
NCT05669001
Phase
Phase 2 Kidney Transplant Research Study
Study Type
Interventional
Participants
Expecting 90 study participants
Last Updated