Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Focal Segmental Glomerulosclerosis (FSGS)
- Kidney Transplantation
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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...
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).
Tracking Information
- NCT #
- NCT02921789
- Collaborators
- Kyowa Kirin Co., Ltd.
- Investigators
- Study Director: Medical Director Astellas Pharma Global Development, Inc.
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