Skip to main content
. 2022 Feb 25;12(2):e050507. doi: 10.1136/bmjopen-2021-050507

Table 1.

Characteristics of studies originally planned to be included

Author (year) Name of the study (Clinicaltrials.gov number) Country Study design Intervention and comparison (number of patients)* Patients Outcomes
Walsh et al (2020)24 PEXIVAS (NCT00987389) Multiple countries Phase III, randomised, open label, 704 patients Intervention: reduced-dose GC therapy (initial dose: 50–75 mg; maintenance dose continues at 5 mg/day from the end of week 23 until at least week 52; accumulative dose less than 60% of the standard) 353 patients with severe AAV (mean age 63 years, 44% female) Primary outcome: a composite of death from any cause or ESKD.
Secondary outcomes: death from any cause, ESKD, sustained remission, serious adverse events, serious infections within 1 year and health-related quality of life.
Comparison: standard-dose GC therapy (initial dose: 50–75 mg; maintenance dose continues at 5 mg/day from the end of week 23 until at least week 52) 351 patients with severe AAV (mean age 63 years, 43% female)
Furuta et al (2021)18 LoVAS (NCT02198248) Japan, multicentric Phase IV, randomised, open label, 140 patients Intervention : low-dose GC treatment (initial dose : 0.5 mg/kg/day; discontinued at 5 months) 70 patients with new diagnosis of AAV (median age: 73; 43% female) Primary outcome: remission rate at 6 months.
Secondary outcomes: time to remission, death, relapse, ESKD and the first serious adverse event, proportion of death, relapse and ESKD for efficacy at 6 months.
Comparison : high-dose GC treatment (initial dose : 1 mg/kg/day; reduced to 10 mg/day by 5 months) 70 patients with new diagnosis of AAV (median age: 74; 37% female)

*Although these two trials are comparisons of different doses of GCs, the regimens are different, and the details are in the text.

AAV, antineutrophil cytoplasmic antibodies associated vasculitis; ESKD, end-stage kidney disease; GCs, glucocorticoids.