Antineutrophil cytoplasmic antibody associated vasculitides with renal involvement: Open challenges in the remission induction therapy

Table 3 Trials for induction of remission in antineutrophil cytoplasmic antibody associated vasculitides with renal involvement and corticosteroids-sparing regimens

Name of the Trial (number of patients)	Inclusion criteria	Treatment groups (drug dose)	Primary end points	Outcome
LoVAS[71] (140)	New clinical diagnosis of MPA or GPA, Age > 20 yr, eGFR > 15 mL/min	Low-dose CCS (0.5 mg/kg per day tapered and off within 6 mo) plus RTX vs High-dose CCS (1.0 mg/kg per day tapered to 10 mg/d within 6 mo) plus RTX	Proportion of the patients achieving remission at 6 mo (BVAS = 0 and CCS < 10 mg)	Ongoing trial (NCT02198248)
PEXIVAS[69] (704)	New or previous clinical diagnosis of MPA or GPA, Age > 15 yr, eGFR < 50 mL/min	without PLEX: normal versus reduced CCS vs with PLEX: normal versus reduced CCS (reduced dose regimen provides approximately 55% of the standard dose regimen over the first 6 mo)	All-cause mortality and ESRD at 2 yr	Ongoing trial (NCT00987389)
CLEAR[73] (67)	New or previous clinical diagnosis of MPA or GPA, Age > 18 yr, eGFR > 20 mL/min	Placebo plus 60 mg prednisone vs Avacopan (30 mg x 2/d) plus 20 mg prednisone vs Avacopan (30 mg x 2/d) without prednisone	Safety of Avacopan in subjects with AAV over the 12-wk treatment period	Avacopan can replace high-dose CCS efficiently and safely in patients with newly diagnosed or relapsing AAV
ADVOCATE[75] (300)		Avacopan in combination with RTX or CYC/AZA vs Prednisone in combination with RTX or CYC/AZA	The proportion of patients achieving disease remission at 26 wk	Ongoing trial (NCT02994927)

AAV: Antineutrophil cytoplasmic antibody associated vasculitides; GPA: Granulomatosis with polyangiitis; MPA: Microscopic polyangiitis; CYC: Cyclophosphamide; AZA: Azathioprine; RTX: Rituximab; CCS: Corticosteroids; PLEX: Plasma exchange; eGFR: Estimated glomerular filtration rate; ESRD: End-stage renal disease; BVAS: Birmingham vasculitis activity score.