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Clinical Trial NCT05772871 for Nephrotic Syndrome in Children is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children Phase 4 402
Clinical Trial NCT05772871 is designed to study Treatment for Nephrotic Syndrome in Children. It is a Phase 4 interventional study that is recruiting, having started on April 26, 2023, with plans to enroll 402 participants. Led by Jianhua Zhou, it is expected to complete by October 30, 2025. The latest data from ClinicalTrials.gov was last updated on June 21, 2024.
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.
Detailed Description
Nephrotic syndrome (NS) is the most frequent glomerular disease in children, with an incidence of 1.15-16.9 per 100,000 children. Children present with the disease at a median age of 2-3 years, and it is twice as common in boys. More than 90% of children who present with NS respond to corticosteroid treatment, and current practice is to treat most patients empirically with prednisone. However, after initial successfu...Show More
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
Conditions
Nephrotic Syndrome in ChildrenOther Study IDs
- HQH-202205
NCT ID Number
Start Date (Actual)
2023-04-26
Last Update Posted
2024-06-21
Completion Date (Estimated)
2025-10-30
Enrollment (Estimated)
402
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Huaiqihuang granule
Children
Nephrotic syndrome
Children
Nephrotic syndrome
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Quadruple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPrednisone, Huaiqihuang granule, and Levamisole placebo In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo. | 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 fo...Show More 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 rela...Show More 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. |
Placebo ComparatorPrednisone, Levamisole, and Huaiqihuang granule placebo In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo. | 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 rela...Show More 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, lo...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Remission time to first relapse | Among patients who get remission after treatment, time from the onset of remission to the first relapse | Start of onset of remission after treatment until first relapse, assessed up to 6-month |
Number of relapses | Among patients who get remission after treatment, number of relapse per patient | Start of randomization until 6-month follow-up |
Relapse rate | Among patients who get remission after treatment, proportion of patients with relapse | Start of randomization until 6-month follow-up |
Incidence of frequently relapse | Among patients who get remission after treatment, proportion of patients with more than two times of relapses within 6-month follow-up | Start of randomization until 6-month follow-up |
Infection rate | Proportion of patients experiencing infection during the treatment. Infections include respiratory tract infections, urinary tract infections, skin infections, gastrointestinal infections, and others. | Start of medication until 6-month follow-up |
Cumulative corticosteroids dosage adjusted by body weight | Total amount of per patient per kilogram cumulative corticosteroids dosage | Start of receiving corticosteroids until 6-month follow-up |
Change in serum creatinine and estimated glomerular filtration rate (eGFR) before and after treatment | The level change of serum creatinine, eGFR between baseline and the last testing result during follow-up | Start of randomization until 6-month follow-up |
Change in serum albumin before and after treatment | The level change of serum albumin between baseline and the last testing result during follow-up | Start of randomization until 6-month follow-up |
Change in urinary albumin/creatinine ratio (ACR) before and after treatment | The level change of urinary albumin/creatinine ratio (ACR) between baseline and the last testing result during follow-up | Start of randomization until 6-month follow-up |
Change in 24h urinary protein (applying to more than 3 years patients) before and after treatment | The level change of 24h urinary protein (applying to more than 3 years patients) between baseline and the last testing result during follow-up | Start of randomization until 6-month follow-up |
Incidence and severity of adverse events (AE) and serious adverse events (SAE) | Start of randomization until 6-month follow-up | |
Incidence and severity of adverse reactions (ADR), serious adverse reactions (SADR), suspicious and unexpected serious adverse reactions (SUSAR) | Start of randomization until 6-month follow-up |
Participation Assistant
Eligibility Criteria
Eligible Ages
Child, Adult
Minimum Age
18 Months
Eligible Sexes
All
- 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.
- 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.
Jianhua ZhouLinkDoc Technology (Beijing) Co. Ltd.Study Responsible Party
Jianhua Zhou, Sponsor-Investigator, Professor, Tongji Hospital
Study Central Contact
Contact: Jianhua Zhou, Dr., 86+13367266559, [email protected]
26 Study Locations in 1 Countries
Anhui
Anhui Children's Hospital, Hefei, Anhui, China
Fang Deng, Contact
Recruiting
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Mo Wang, Contact
Recruiting
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, China
Zihua Yu, Contact
Recruiting
People's Liberation Army Joint Logistics Force No. 900 Hospital, Fuzhou, Fujian, China
Xiaojing Nie, Contact
Recruiting
Guangdong
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Xiaoyun Jiang, Contact
Recruiting
Hebei
Hebei Children's Hospital, Shijiazhuang, Hebei, China
Dongfeng Zhang, Contact
Recruiting
Heilongjiang
Harbin Children's Hospital, Harbin, Heilongjiang, China
Fang Ning, Contact
Recruiting
Henan
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Ziming Han, Contact
Recruiting
Henan Children's Hospital, Zhengzhou, Henan, China
Cuihua Liu, Contact
Recruiting
The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Jianhua Zhang, Contact
Recruiting
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Jianhua Zhou, Contact
Recruiting
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiaowen Wang, Contact
Recruiting
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
Zhihui Li, Contact
Recruiting
Jiangsu
Children's Hospital of Soochow University, Suzhou, Jiangsu, China
Xiaozhong Li, Contact
Recruiting
Jilin
Baiqiu'en First Hospital of Jilin University, Changchun, Jilin, China
Kaishu Zhao, Contact
Recruiting
Liaoning
Dalian Women and Children's Medical Centre, Dalian, Liaoning, China
Mei Han, Contact
Recruiting
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Yue Du, Contact
Recruiting
Shandong
Shandong Provincial Hospital, Jinan, Shandong, China
Shunzhen Sun, Contact
Recruiting
Shanghai Municipality
Shanghai Children's Hospital, Shanghai, Shanghai Municipality, China
Wenyan Huang, Contact
Recruiting
Shanxi
Shanxi Children's Hospital, Taiyuan, Shanxi, China
Lijun Zhao, Contact
Recruiting
Sichuan
West China Second Hospital of Sichuan University, Chengde, Sichuan, China
Yuhong Tao, Contact
Recruiting
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China
Shipin Feng, Contact
Recruiting
Tianjin Municipality
Tianjin Children's Hospital, Tianjin, Tianjin Municipality, China
Wenhong Wang, Contact
Recruiting
Xinjiang
Xinjiang Uiger Municipal People's Hospital, Ürümqi, Xinjiang, China
Feiyan Wang, Contact
Recruiting
Zhejiang
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, Contact
Recruiting
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China
Xiaohui Qiao, Contact
Recruiting