Stratified Therapy on Pediatric AAGN

Launched by WANG MO · Jul 23, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at how different treatments affect children with a condition called ANCA-associated nephritis, which is a type of kidney inflammation. The goal is to see how well these treatments work in helping children recover and to compare their safety. Researchers will be collecting information from kids aged 5 to 17 who are newly diagnosed with this condition. They will assess how different therapies, based on a specific risk classification, impact the children’s health outcomes and any possible side effects they may experience.

To be eligible for this trial, children must have received a kidney biopsy confirming their diagnosis and show clear signs of kidney issues. However, kids who have severe kidney damage, rely on dialysis, or have other serious infections or kidney diseases cannot join. Participants will receive specific treatments based on their risk level and be closely monitored for their health and recovery during the study. This trial aims to help doctors find better ways to treat children with this serious condition.

Gender

ALL

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.