Trials / Completed
CompletedNCT02921789
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 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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 67 (actual)
- Sponsor
- Astellas Pharma Global Development, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The study consisted 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 entered into a Screening Period (Days -21 to -1 prior to transplant), and underwent a Transplant (Day 0 \[zero\]), and then followed for up to 12 months in the Post-Transplant Period (Day 0 through 12 months post-transplant).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bleselumab | Intravenous infusion |
| DRUG | Basiliximab | Bolus injection |
| DRUG | Mycophenolate Mofetil (MMF) | Oral Intravenous |
| DRUG | Tacrolimus Capsules | Oral Capsule |
| DRUG | Methylprednisone | Oral or Intravenous |
| DRUG | Prednisone | Oral Tablet |
Timeline
- Start date
- 2017-05-22
- Primary completion
- 2020-12-11
- Completion
- 2021-05-18
- First posted
- 2016-10-03
- Last updated
- 2024-12-04
- Results posted
- 2022-01-05
Locations
23 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02921789. Inclusion in this directory is not an endorsement.