Evaluating treatments for children with ANCA-associated nephritis

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

This study is testing different treatment combinations for children with ANCA-associated nephritis to see which works best for improving their kidney health and overall safety.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 5 Years to 17 Years
• Sex: All
• Sponsor: Children's Hospital of Chongqing Medical University (Academic / other)
• Drugs / interventions: rituximab, cyclophosphamide
• Locations: 1 site (Chongqing, Chongqing)
• Trial ID: NCT05969522 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to collect clinical information from children diagnosed with ANCA-associated nephritis at Children's Hospital Affiliated to Chongqing Medical University and partner centers. It will evaluate the differences in survival, renal outcomes, and adverse reactions among children receiving various interventions based on the revised PARRG risk stratification. The study will compare the efficacy and safety of glucocorticoid combined with rituximab and cyclophosphamide in high-risk patients against glucocorticoid combined with rituximab in low and middle-risk patients. The goal is to determine the best treatment approach for this condition.

Who should consider this trial

Good fit: Ideal candidates for this study are newly diagnosed pediatric patients aged 5-17 years with ANCA-associated nephritis who meet specific diagnostic criteria.

Not a fit: Patients who do not meet the inclusion criteria or have other forms of kidney disease unrelated to ANCA-associated nephritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for children suffering from ANCA-associated nephritis.

How similar studies have performed: While there have been studies on ANCA-associated vasculitis, this specific approach using PARRG risk stratification in a pediatric population is novel.

Eligibility criteria

Inclusion Criteria:

* 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:

1. Hematuria: gross hematuria or microscopic hematuria: 3 times microscopic hematuria within 1 week: red blood cells \&gt 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);
2. 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;
3. Renal insufficiency: increased serum creatinine \> 10% base or decreased creatinine clearance \> 25%.

Exclusion Criteria:

- 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.

Where this trial is running

Chongqing, Chongqing

• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing, China (Recruiting)

Study contacts

• Study coordinator: cheng Zhong

Conditions Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; ANCA-Associated Glomerulonephritis