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The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
Sponsor: Jianhua Zhou
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Months - 18 Years
Study Type
INTERVENTIONAL
Enrollment
402
Start Date
2023-04-26
Completion Date
2025-10-30
Last Updated
2024-06-21
Healthy Volunteers
No
Conditions
Interventions
Huaiqihuang granule
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
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
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
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
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.
Locations (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