Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

Phase 2 Completed 67 enrolled Astellas Pharma Global Development, Inc. Kyowa Kirin, Inc. · collab

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

Outcome

Missed primary endpoint

registry analysis (superiority test); SOC Regimen vs Bleselumab Regimen; p = 0.3705; Difference -12.7 (95% CI -34.5 to 9.0); Fisher Exact NCT02921789 ↗

Publications

Shoji J, Goggins WC, Wellen JR, Cunningham PN, Johnston O, Chang SS, Solez K, Santos V, Larson TJ, Takeuchi M, Wang X. Efficacy and Safety of Bleselumab in Preventing the Recurrence of Primary Focal Segmental Glomerulosclerosis in Kidney Transplant Recipients: A Phase 2a, Randomized, Multicenter Study. Transplantation. 2024 Aug 1;108(8):1782-1792. doi: 10.1097/TP.0000000000004985. Epub 2024 Jul 20.

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