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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosc

Brief 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 the recurrence of Focal Segmental Glomerulosclerosis (FSGS) as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology through 3 months post-transplant.

Detailed Summary: The study will consist of the following periods: Screening (Days -21 to -1), Transplant (Day 0), Post-Transplant (Day 0/post-skin closure through 12 months post-transplant). All subjects will enter into a Screening Period (Days -21 to -1 prior to transplant), undergo a Transplant (Day 0 [zero]), and are then to be followed for up to 12 months in the Post-Transplant Period (Day 0 through 12 months post-transplant).
Sponsor: Astellas Pharma Global Development, Inc.

Current Primary Outcome: Recurrence of focal segmental glomerulosclerosis (FSGS) as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology through 3 months post-transplant [ Time Frame: UP to 3 months post-transplant ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Recurrence of FSGS as defined by nephrotic range proteinuria with protein-creatinine ratio (> 3.0 g/g) or initiation of plasmapheresis and no other evident etiology [ Time Frame: Up to 12 months post-transplant ]
  • Biopsy-proven recurrence (blinded, central read) of FSGS in transplanted kidney [ Time Frame: Up to 12 months post-transplant ]
  • Biopsy provide acute rejection (BPAR) (Banff Grade ≥ 1, local read) [ Time Frame: Up to 12 months post-transplant ]


Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: September 30, 2016
Date Started: December 2016
Date Completion: March 2019
Last Updated: February 23, 2017
Last Verified: February 2017