Status:
UNKNOWN
Stratified Therapy on Pediatric AAGN
Lead Sponsor:
Wang Mo
Conditions:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
ANCA-Associated Glomerulonephritis
Eligibility:
All Genders
5-17 years
Phase:
PHASE4
Brief Summary
Clinical information of children with ANCA-associated nephritis admitted to Children's Hospital Affiliated to Chongqing Medical University and partner centers from January 1, 2023 to December 31, 2023...
Eligibility Criteria
Inclusion
- 1\) Newly diagnosed AAGN patients with onset age of 5-17 years, complete renal biopsy and regular follow-up in the hospital; 2) All enrolled children met the following inclusion criteria: ANCA classification criteria: Patients who meet the 2007 European Medicines Agency (EMA) classification algorithm or the 2012 CHCC definition. Clinical classification includes: micropolyvasculitis (MPA), granulomatous polyvasculitis (GPA) and eosinophilic granulomatous polyvasculitis (EGPA);
- AAGN diagnostic criteria: ANCA vasculitis combined with any of the following:
- Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuria within 1 week: red blood cells \> in urine routine; 3 / high magnification field (HP) or \> 17 /ul (higher than normal value, can be adjusted according to the standard of the laboratory of each center);
- proteinuria: meet any of the following: ① 3 times in 1 week urine routine protein positive; 2) 24h urinary protein quantification \> 150 mg or urinary protein/creatinine (mg/mg)\> 0.2; 3 urinary microalbumin higher than normal for 3 times in 1 week;
- Renal insufficiency: increased serum creatinine \> 10% base or decreased creatinine clearance \> 25%.
Exclusion
- \- 1) Patients who relied on dialysis for more than 1 month at the time of diagnosis, or the proportion of glomerular sclerosis ≥75% at the time of renal biopsy; 2) Patients with severe infection (such as diffuse peritonitis, severe pneumonia, cellulitis, active Epstein-Barr virus infection, active cytomegalovirus infection, hepatitis B virus infection, tuberculosis infection, fungal infection, etc.) and tumor.
- 3\) Patients with other primary or secondary kidney diseases (such as IgA nephropathy, membranous nephropathy, anti-glomerular basement membrane nephritis, polycystic kidney disease, renal dysplasia, urinary tract malformation, etc.); 4) Parents or children refused to join the group.
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05969522
Start Date
January 1 2023
End Date
December 31 2025
Last Update
August 1 2023
Active Locations (1)
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1
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400015