Actively Recruiting
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
Led by Jianhua Zhou · Updated on 2024-06-21
402
Participants Needed
26
Research Sites
131 weeks
Total Duration
On this page
Sponsors
J
Jianhua Zhou
Lead Sponsor
L
LinkDoc Technology (Beijing) Co. Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 1.5 to 18 years
- Diagnosed with primary nephrotic syndrome according to 2016 evidence-based guidelines
- Estimated glomerular filtration rate (eGFR) of 90 ml/min/1.73m2 or higher at enrollment
- Serum albumin level below 30 g/L and morning urine protein of 4+ or urinary albumin/creatinine ratio of 2.0 g/g or higher at enrollment
- Volunteered to participate and signed informed consent; legal guardians sign for children under 8 years old
You will not qualify if you...
- Diagnosed with steroid-resistant nephrotic syndrome
- Received Prednisone, other corticosteroids, or immunosuppressants within 3 months before enrollment
- Secondary nephrotic syndrome caused by lupus nephritis, hepatitis B nephritis, purpura nephritis, or infections like EB virus or cytomegalovirus
- Presence of autoimmune disorders, primary immunodeficiency, or cancer
- Serious diseases involving cardiovascular, liver, hematopoietic, mental health, or other major systems
- History or current serious infections such as tuberculosis
- Active viral infections including HIV, hepatitis B or C
- History of diabetes
- Abnormal liver function with enzyme levels exceeding twice the upper normal limit
- Participation in other ongoing clinical trials
- Any other condition considered unsuitable by the researchers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Anhui Children's Hospital
Hefei, Anhui, China
Actively Recruiting
2
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Actively Recruiting
3
Fujian Children's Hospital
Fuzhou, Fujian, China
Actively Recruiting
4
People's Liberation Army Joint Logistics Force No. 900 Hospital
Fuzhou, Fujian, China
Actively Recruiting
5
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
6
Hebei Children's Hospital
Shijiazhuang, Hebei, China
Actively Recruiting
7
Harbin Children's Hospital
Harbin, Heilongjiang, China
Actively Recruiting
8
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China
Actively Recruiting
9
Henan Children's Hospital
Zhengzhou, Henan, China
Actively Recruiting
10
The First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Actively Recruiting
11
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
12
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
13
Hunan Children's Hospital
Changsha, Hunan, China
Actively Recruiting
14
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
15
Baiqiu'en First Hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
16
Dalian Women and Children's Medical Centre
Dalian, Liaoning, China
Actively Recruiting
17
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Actively Recruiting
18
Shandong Provincial Hospital
Jinan, Shandong, China
Actively Recruiting
19
Shanghai Children's Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
20
Shanxi Children's Hospital
Taiyuan, Shanxi, China
Actively Recruiting
21
West China Second Hospital of Sichuan University
Chengde, Sichuan, China
Actively Recruiting
22
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan, China
Actively Recruiting
23
Tianjin Children's Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
24
Xinjiang Uiger Municipal People's Hospital
Ürümqi, Xinjiang, China
Actively Recruiting
25
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
26
Ningbo Women's and Children's Hospital
Ningbo, Zhejiang, China
Actively Recruiting
Research Team
J
Jianhua Zhou, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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