This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN).
This study is an open-label, single-arm, exploratory study designed to evaluate the efficacy and safety of Obinutuzumab beta combined with a rapid-tapering glucocorticoid regimen in patients with new-onset ANCA-associated glomerulonephritis (AAGN). The primary objective is to assess the complete remission rate at Week 24.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous infusion of Obinutuzumab beta administered during the induction phase.
Oral glucocorticoid induction starting alongside Obinutuzumab beta, following a prespecified rapid tapering schedule aimed at complete discontinuation by Week 24.
Chinese PLA General Hospital
Beijing, China
RECRUITINGComplete Remission (CR) rate
Proportion of participants achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 and complete withdrawal of oral glucocorticoids
Time frame: Month 6 (Week 24)
Renal Remission (RR) rate
Proportion of participants achieving renal remission, defined by stabilization or improvement in renal function and resolution of active urinary sediment.
Time frame: Up to Month 12
Change in estimated Glomerular Filtration Rate (eGFR)
Dynamic change of eGFR from baseline.
Time frame: Up to Month 12
Change in proteinuria
Dynamic change of 24-hour urine protein or Urine Protein-to-Creatinine Ratio (UPCR) from baseline.
Time frame: Up to Month 12
Incidence of End-Stage Renal Disease (ESRD) or death
Proportion of participants reaching the composite endpoint of ESRD or all-cause mortality.
Time frame: Up to Month 12
Overall Remission rate
Proportion of participants achieving a BVAS of 0.
Time frame: Up to Month 12
Proportion of participants achieving peripheral B-cell depletion
Pharmacodynamic assessment of peripheral B-cell count changes from baseline.
Time frame: Up to Month 12
Change in ANCA serological status and titer levels
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of participants achieving ANCA negativity and changes in ANCA titers from baseline.
Time frame: Up to Month 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Safety and tolerability evaluated by the number and severity of AEs graded according to CTCAE v6.0.
Time frame: Up to Month 12