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Selective CD28 Blockade in Renal Transplant Recipients

Kidney Transplantation Clinical Trial

Official title:
Selective CD28 Blockade With Lulizumab Compared to CNI Inhibition With Tacrolimus in Renal Transplant Recipients

Clinical Trial Summary

The aim of this study is to evaluate the safety and efficacy of lulizumab, a CD28-specific domain antibody (CD28 dAb), compared to tacrolimus, as the primary immunosuppressant in first-time renal transplant recipients.

Clinical Trial Description

This is a phase 2a, open-label, prospective, randomized (1:1), controlled, single center study evaluating the safety and efficacy of lulizumab (a CD28 specific domain antibody [CD28dAb]) compared to tacrolimus as the primary immunosuppressant in first-time renal transplant recipients. The study will take place at Emory University Hospital in Atlanta, Georgia, United States (US). There are two arms/groups in this study, the Control (tacrolimus) group and the Investigational (lulizumab) group. The two arms will be assigned to treatment regimens for the first 12 months after transplantation; at that point, all participants in each arm will be transitioned to a physician directed Standard of Care (SOC) immunosuppressive regimen, and all participants will be assessed at 15 months after transplantation. All participants will receive induction therapy with Thymoglobulin and Methylprednisolone and maintenance therapy with Mycophenolate Mofetil (MMF) and Prednisone. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04903054
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Withdrawn
Phase Phase 2
Start date January 10, 2022
Completion date September 22, 2022
View Details
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