Overview

Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

Status:
Completed

Trial end date:
2021-05-18

Target enrollment:

Participant gender:

Summary

The purpose of this study is to assess the efficacy of the bleselumab regimen (basiliximab induction, tacrolimus, steroids and bleselumab) compared with the Standard of Care (SOC) regimen (basiliximab induction, tacrolimus, steroids and mycophenolate mofetil [MMF]) in the prevention of recurrent Focal Segmental Glomerulosclerosis (rFSGS) defined as nephrotic range proteinuria with protein-creatinine ratio (≥ 3.0 g/g) through 3 months post-transplant. Death, graft loss or lost to follow-up will be imputed as rFSGS.

Phase:

Phase 2

Details

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Collaborators:

Kyowa Hakko Kirin Company, Limited
Kyowa Kirin Co., Ltd.

Treatments:

Basiliximab
Mycophenolate mofetil
Mycophenolic Acid
Prednisone
Tacrolimus