At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 Glomerulosclerosis in de Novo Kidney Transplant Recipients
In Brief
A Phase 2 clinical trial evaluating Bleselumab, Basiliximab, and 4 other interventions for Kidney Transplantation and Primary Focal Segmental Glomerulosclerosis (FSGS). Completed, enrolled 67 participants across 23 sites in 2 countries.
Detailed Summary
The purpose of this study was 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 were imputed as rFSGS.
Study Details
Timeline
Interventions
Intravenous infusion
Bolus injection
Oral Intravenous
Oral Capsule
Oral or Intravenous
Oral Tablet