The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary 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
1 other identifier
interventional
402
1 country
26
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Apr 2023
Typical duration for phase_4
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 24, 2023
CompletedFirst Posted
Study publicly available on registry
March 16, 2023
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedJune 21, 2024
June 1, 2024
2.4 years
February 24, 2023
June 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintaining remission rate
At the end of the study, the proportion of patients who maintained urine protein negative without relapse (removed the patients who developed steroid resistance at the first 4 weeks of treatment of Prednisone).
Start of randomization until 6-month follow-up
Secondary Outcomes (12)
Remission time to first relapse
Start of onset of remission after treatment until first relapse, assessed up to 6-month
Number of relapses
Start of randomization until 6-month follow-up
Relapse rate
Start of randomization until 6-month follow-up
Incidence of frequently relapse
Start of randomization until 6-month follow-up
Infection rate
Start of medication until 6-month follow-up
- +7 more secondary outcomes
Other Outcomes (14)
Change in blood pressure before and after treatment
Start of randomization until 6-month follow-up
Change in height before and after treatment
Start of randomization until 6-month follow-up
Change in body weight before and after treatment
Start of randomization until 6-month follow-up
- +11 more other outcomes
Study Arms (2)
Prednisone, Huaiqihuang granule, and Levamisole placebo
EXPERIMENTALIn this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo.
Prednisone, Levamisole, and Huaiqihuang granule placebo
PLACEBO COMPARATORIn this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo.
Interventions
Huaiqihuang Granule, oral administration, recommended daily dose: for body weight \<10 kg, 5g, twice a day; for 10 kg ≤ body weight \<20 kg, 10g, twice a day; for 20 kg≤body weight \<30 kg, 15g, twice a day; for 30 kg≤body weight \<50 kg, 20g, twice a day; for body weight\>50 kg, 30g, twice a day. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Prednisone, oral administration, recommended dose: 2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks. If patients have relapsed during reducing dosage or withdrawal, the patients will receive Prednisone for 8 weeks again \[2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks\]. If a second relapse is observed, patients will receive immunosuppressants and then withdraw from the trial.
Levamisole placebo, 1.25 mg/kg. once daily. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Levamisole, 1.25 mg/kg. once daily. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Huaiqihuang Granule placebo, oral administration, recommended daily dose: for body weight \<10 kg, 5g, twice a day; for 10 kg ≤ body weight \<20 kg, 10g, twice a day; for 20 kg≤body weight \<30 kg, 15g, twice a day; for 30 kg≤body weight \<50 kg, 20g, twice a day; for body weight\>50 kg, 30g, twice a day. Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jianhua Zhoulead
- LinkDoc Technology (Beijing) Co. Ltd.collaborator
Study Sites (26)
Anhui Children's Hospital
Hefei, Anhui, China
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fujian Children's Hospital
Fuzhou, Fujian, China
People's Liberation Army Joint Logistics Force No. 900 Hospital
Fuzhou, Fujian, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Hebei Children's Hospital
Shijiazhuang, Hebei, China
Harbin Children's Hospital
Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Henan Children's Hospital
Zhengzhou, Henan, China
The First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Hunan Children's Hospital
Changsha, Hunan, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Baiqiu'en First Hospital of Jilin University
Changchun, Jilin, China
Dalian Women and Children's Medical Centre
Dalian, Liaoning, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Provincial Hospital
Jinan, Shandong, China
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Shanxi Children's Hospital
Taiyuan, Shanxi, China
West China Second Hospital of Sichuan University
Chengde, Sichuan, China
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Tianjin Children's Hospital
Tianjin, Tianjin Municipality, China
Xinjiang Uiger Municipal People's Hospital
Ürümqi, Xinjiang, China
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Ningbo Women's and Children's Hospital
Ningbo, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianhua Zhou, Dr.
Tongji Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 24, 2023
First Posted
March 16, 2023
Study Start
April 26, 2023
Primary Completion
September 15, 2025
Study Completion
October 30, 2025
Last Updated
June 21, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share