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NCT02921789 · ClinicalTrials.gov registry record · Phase 2
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
NCT02921789: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT02921789 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 67 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02921789, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
Study 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.
Primary Outcome
rFSGS was defined as nephrotic range proteinuria with a protein/creatinine ratio (≥ 3.0 g/g). Death, graft loss or lost to follow-up was imputed as rFSGS.
Interventions
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Basiliximab
- DRUG Bleselumab
- DRUG Tacrolimus Capsules
- DRUG Methylprednisone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2017-05-22 |
| Est. Completion | 2021-05-18 |
| Phase | Phase 2 |
What the finished NCT02921789 record still lists
NCT02921789 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil (MMF) is the first listed.
NCT02921789 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02921789 about?
NCT02921789 is a clinical study titled "Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients". 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 ...
What is the current status of trial NCT02921789?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2017-05-22. Estimated completion is 2021-05-18.
What interventions are being tested in trial NCT02921789?
The interventions under investigation include: Mycophenolate Mofetil (MMF) (DRUG), Basiliximab (DRUG), Bleselumab (DRUG), Tacrolimus Capsules (DRUG), Methylprednisone (DRUG).
Who is sponsoring clinical trial NCT02921789?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02921789's enrollment target sits among peer trials
67 974th of 2000 higher than 1,026 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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