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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 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 67 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02921789
The ClinicalTrials.gov registry entry for NCT02921789 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Astellas Pharma Global Development, which has 168 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Mycophenolate Mofetil (MMF) is the first listed.
NCT02921789 reports 0 study locations.
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.
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