drugset / Trial / NCT02921789
Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-05-22
- Primary completion
- 2020-12-11
- Completion
- 2021-05-18
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Mycophenolate Mofetil | Small molecule | 1 g | Oral |
| Subject | bleselumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Basiliximab | Monoclonal antibody | 20 mg | Intravenous |
| Background | Methylprednisone | Unknown | 60 mg | Oral |
| Background | Prednisone | Other / unclassified | 5 mg | Oral |
| Background | Prednisone | Other / unclassified | 10 mg | Oral |
| Background | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |