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Stratified Therapy on Pediatric AAGN Based on Risk Assessment: A Prospective, Multicenter, Open, Tendentious Matched Control Clinical Study

Stratified Therapy on Pediatric AAGN Based on Risk Assessment: A Prospective, Multicenter, Open, Tendentious Matched Control Clinical Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067726
Enrollment
Unknown
Registered
2023-01-19
Start date
2023-01-20
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ANCA associated glomerulonephritis

Interventions

High risk group:Glucocorticoid + 4 doses of rituximab + 2 times of intravenous cyclophosphamide pulse therapy
Low and medium risk group:Glucocorticoid + 4 doses of rituximab

Sponsors

Children's Hospital Affiliated to Chongqing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. The initial age of AAGN patients was 5-17 years old. The renal biopsy was completed and followed up in the hospital; 2. All enrolled children met the following inclusion criteria: (1) ANCA classification diagnostic criteria: patients who meet the classification algorithm of European Drug Administration (EMA) in 2007 or the definition of CHCC in 2012. Clinical classification includes: including microscopic polyangitis (MPA), granulomatosis with polyangitis (GPA) and eosinophilic granulomatosis with polyangitis (EGPA); (2) AAGN diagnostic criteria: ANCA vasculitis with any of the following: 1) Hematuria: gross hematuria or microscopic hematuria: three times of microscopic hematuria within a week: red blood cells in urine routine>3/high power field (HP) or > 17/ul (higher than the normal value, which can be adjusted according to the standards of each central laboratory); 2) Proteinuria: Those who meet any of the following requirements: routine urine protein is positive three times within a week; 24h urine protein content > 150 mg or urine protein/creatinine (mg/mg) > 0.2; Urinary microalbumin was higher than the normal value three times in a week; 3) Renal insufficiency: blood creatinine increased > basaline 10% or creatinine clearance decreased > 25%.

Exclusion criteria

Exclusion criteria: 1. The diagnosis depends on dialysis for more than 1 month, or the proportion of glomerular sclerosis at renal biopsy is >= 75%; 2. Patients with severe infection (such as diffuse peritonitis, severe pneumonia, cellulitis, active EB virus infection, active cytomegalovirus infection, hepatitis B virus infection, tuberculosis infection, fungal infection, etc.) and tumor patients; 3. Those with other primary or secondary renal 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 refuse to join the group.

Design outcomes

Primary

MeasureTime frame
Efficiency;

Countries

China

Contacts

Public ContactMo Wang

Children's Hospital Affiliated to Chongqing Medical University

wangmo_cqmu@163.com+86 13983649255

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026