This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of primary nephrotic syndrome (PNS) in children.
Age from 1.5 to 18 years;
According to the Evidence-based Guideline for Diagnosis and Treatment of Hormone-sensitive, Relapsed/dependent Nephrotic Syndrome in Children (2016), children diagnosed with PNS;
At enrollment, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2；
At enrollment, serum albumin level below 30g/L, and morning urine protein is 4+ or urinary albumin/creatinine ratio (ACR)≥2.0g/g;
Children who were diagnosed as steroid-resistant NS;
Patients who received Prednisone, other corticosteroids (like Prednisolone, Methylprednisolone), or immunosuppressants (Tacrolimus, Mycophenolate Mofetil, Cyclosporine A, Rituximab, Cyclophosphamide) within 3 months before enrollment;
Secondary NS caused by lupus nephritis, hepatitis B associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
With combined diseases of autoimmune disorder or primary immunodeficiency or malignancy;
Jianhua Zhou
Lead sponsor
Tongji Hospital
Sponsor institution
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator