drugset / Trial / NCT05969522

Stratified Therapy on Pediatric AAGN

NCT05969522

Phase 4 Unknown 200 enrolled Wang Mo
Non-randomizedSequentialOpen-labelTreatment

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 was collected: To evaluate and compare the differences in survival, renal outcomes, and adverse reactions in children with ANCA-associated nephritis given different interventions according to the revised PARRG risk stratification, and to evaluate the superiority of ANCA-associated nephritis given according to the revised PARRG risk stratification. (2) To evaluate the efficacy and safety of glucocorticoid combined with rituximab and cyclophosphamide as induction regimen in high-risk group and glucocorticoid combined with rituximab as induction regimen in children with ANCA-associated nephritis (AAGN) in low and middle risk group based on PARRG risk stratification

Timeline

Start
2023-01-01
Primary completion
2023-12-31
Completion
2025-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 7.5 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 10 mg/kg Intravenous
Subject Methylprednisolone Other / unclassified 15 mg/kg Intravenous
Subject Methylprednisolone Other / unclassified 30 mg/kg Intravenous
Subject Prednisone Other / unclassified 1.5 mg/kg Oral
Subject Prednisone Other / unclassified 2 mg/kg Oral
Subject Rituximab Monoclonal antibody 375 mg/m2