NCT04903054

Selective CD28 Blockade in Renal Transplant Recipients

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Kidney Transplantation
• Renal Transplant Recipients

Interventions

Type	Name	Description
BIOLOGICAL	Lulizumab	Lulizumab is a pegylated, humanized monovalent domain antibody construct that is specific for human cluster of differentiation CD28.
DRUG	Tacrolimus	Standard of Care: Renal transplant rejection prophylaxis.
BIOLOGICAL	Thymoglobulin®	Standard of Care: Renal transplant rejection prophylaxis.
DRUG	Methylprednisolone	Standard of Care: Renal transplant rejection prophylaxis.
DRUG	Mycophenolate Mofetil	Standard of Care: Renal transplant rejection prophylaxis.
DRUG	Prednisone	Standard of Care: Renal transplant rejection prophylaxis.

Timeline

• Start date: 2022-01-10
• Primary completion: 2022-09-22
• Completion: 2022-09-22
• First posted: 2021-05-26
• Last updated: 2023-03-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study