Home › Trials › NCT05772871

Combining Prednisone with Huaiqihuang Granule for treating Nephrotic Syndrome in children

Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study

Phase 4 Interventional Tongji Hospital · NCT05772871

This study is testing if combining a traditional Chinese medicine called Huaiqihuang Granule with Prednisone can help children with nephrotic syndrome do better than just using Prednisone with another medication.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment402 (estimated)
Ages18 Months to 18 Years
SexAll
SponsorTongji Hospital Academic / other
Drugs / interventionsRituximab, Cyclophosphamide, Prednisone
Locations26 sites (Hefei, Anhui and 25 other locations)
Trial IDNCT05772871 on ClinicalTrials.gov

What this trial studies

This non-inferiority study aims to evaluate the effectiveness of combining Prednisone with Huaiqihuang Granule compared to Prednisone with Levamisole in treating primary nephrotic syndrome in children. Nephrotic syndrome is a common kidney disorder in children, often requiring long-term corticosteroid treatment, which can lead to significant side effects. The study will involve approximately 402 participants across 20 research centers, assessing the potential benefits of incorporating Huaiqihuang Granule, a traditional Chinese medicine, to reduce relapse rates and improve overall treatment outcomes. Participants will be closely monitored for efficacy and safety throughout the study.

Who should consider this trial

Good fit: Ideal candidates are children aged 1.5 to 18 years diagnosed with primary nephrotic syndrome who meet specific clinical criteria.

Not a fit: Patients diagnosed with steroid-resistant nephrotic syndrome or those who have recently received corticosteroids or immunosuppressants may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes and reduced relapse rates for children suffering from nephrotic syndrome.

How similar studies have performed: Previous studies have shown promising results for the use of Huaiqihuang Granule in combination with corticosteroids, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Hefei, Anhui and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nephrotic Syndrome in ChildrenHuaiqihuang granuleChildrenNephrotic syndrome
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.