ANCA-Associated Rapidly Progressive Glomerulonephritis
Conditions
Sponsors
The First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Age >=18 years and 30% or creatinine clearance decreased by >25% within the past 4 weeks, after exclusion of other causes and attributable to active nephritis; 4.MPO- or PR3-ANCA positive; 5.Patients or their legal representatives must provide written informed consent prior to any study-specific examinations or procedures.
Exclusion criteria
Exclusion criteria: 1.Failure to sign a written informed consent form or inability/unwillingness to comply with the study protocol as determined by the investigator; 2.History of cardiovascular or cerebrovascular events (such as myocardial infarction, unstable angina, ventricular arrhythmia, New York Heart Association Class II–IV heart failure, stroke, etc.) or infection events requiring hospitalization within the past 12 weeks; 3.Known allergy to any component of anti-CD20 monoclonal antibodies or eculizumab; 4.Congenital or acquired immunodeficiency, or patients with concurrent active infections such as active hepatitis, active tuberculosis, or active cytomegalovirus (CMV) infection; 5.Patients with other serious physiological or psychological conditions deemed unsuitable for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate(defined as absence of clinical manifestations of vasculitis and glomerulonephritis, with BVAS=0 and stable or improved eGFR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Kidney survival rate;MPO or PR3 evels/titers;Magnitude of corticosteroid reduction / Degree of glucocorticoid tapering;Recurrence rate; | — |
Countries
China
Contacts
Public ContactHan Fei
Kidney Disease Center, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Outcome results
None listed