The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children

• Status: Not yet recruiting
• Trial end date: 2025-10-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jianhua Zhou
• Collaborator: LinkDoc Technology (Beijing) Co. Ltd.
• Treatments: Levamisole; Prednisone

Criteria

Inclusion Criteria:

• 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;

• Volunteered to participate in this study and signed informed consent. For children less than 8 years, legal guardians need to sign the informed consent.

Exclusion Criteria:

• 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;

• With combined diseases of the cardiovascular, liver, hematopoietic system, mental disorders, and other serious diseases;

• With serious infectious diseases (like tuberculosis) in the past or at present;

• With combined diseases of Human immunodeficiency virus (HIV), hepatitis B and /or C virus (HBV, HCV), and other active virus infections;

• History of diabetes;

• Abnormal liver function: alanine aminotransferase and aspartate aminotransferase levels exceed twice the upper limit of the normal range;

• Participation in other ongoing clinical trials;

• Other reasons that the researcher considers unsuitable to participate in this study.