The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
- Conditions
- Nephrotic Syndrome
- Registration Number
- NCT03332420
- Lead Sponsor
- Qidong Gaitianli Medicines Co., Ltd
- Brief Summary
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome.
- Detailed Description
This is a multisite, open-label, prospective and registered study designed to evaluate the efficacy and safety of Huai-Qi-Huang granule in children with primary nephrotic syndrome(PNS). The study will be Planned at 1500 participants, and subjects will be on study for up to one year. Data will be collected by authorized physicians for 48 weeks. all of the data included demographic characteristics, information about PNS, laboratory tests and adverse events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1507
- In accordance with Pediatric Branch , the Chinese Medical Association in 2009: guidelines for diagnosis and treatment of common kidney diseases in children (for trial)Ⅰ. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; Ⅲ.Diagnostic criteria for the diagnostic and evidence-based guidelines for hormone-resistant nephrotic syndrome, which means children who are diagnosed with primary nephrotic syndrome should be included;
- Age from 1 to18;
- ALT and AST levels do not exceed twice the upper limit of the normal range;;
- Provision of written informed consent by legal guardians.
- a variety of secondary nephrotic syndromes are caused by infectious diseases such as lupus nephritis, hepatitis b associated nephritis, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
- History of diabetes or examinations showed elevated blood glucose levels;
- Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
- Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
- Patients who are unlikely to adhere to the protocol.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Duration of positive urine protein test changing to the negative result 48 weeks after treatment Duration of positive urine protein test changing to the negative result was measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
The decrease of 24-hour urine protein level 48 Weeks after treatment Compared 24-hour urine protein level between baseline and follow-up timepoint, measured from day 1 until time of positive urine protein test changing to negative, assessed up to 48 weeks.
The ratio of positive to negative urine protein 48 Weeks after treatment The proportion of negative urine protein subjects to the total number of subjects, measured from day 1 until the time of positive urine protein test changing to negative, assessed up to 48 weeks.
- Secondary Outcome Measures
Name Time Method Recurrence rate of PNS 48 Weeks after treatment The proportion of recurrent subjects to the total number of subjects.
Recovery of blood albumin levels 48 Weeks after treatment Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks.
Rates of infectious complications of PNS 48 Weeks after treatment The proportion of complicated infectious subjects to the total number of subjects.
Trial Locations
- Locations (17)
Henan Children's Hospital
🇨🇳Zhengzhou, Henan, China
Harbin Children's Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Weihui, Henan, China
Benq Medical Center
🇨🇳Nanjing, Jiangsu, China
Children's Hospital of Soochow University
🇨🇳Suzhou, Jiangsu, China
Xuzhou Children's Hospital
🇨🇳Xuzhou, Jiangsu, China
Jiangxi Provincal Children's Hospital
🇨🇳Nanchang, Jiangxi, China
Children's Hospital Capital Institute Of Pediatrics
🇨🇳Beijing, Beijing, China
Children's Hospital of Nanjing Medical University
🇨🇳Nanjing, Jiangsu, China
Wuxi Children's Hospital
🇨🇳Wuxi, Jiangsu, China
The first Bethune Hospital of Jilin University
🇨🇳Changchun, Jilin, China
General Hospital of Ningxia Medical University
🇨🇳Yinchuan, Ningxia, China
Children's Hospital of Shanxi
🇨🇳Taiyuan, Shanxi, China
Urumqi first people's Hospital
🇨🇳Ürümqi, Xinjiang, China
Chengdu Women's and Children's Central Hospital
🇨🇳Chengdu, Sichuan, China
Tianjin Children's Hospital
🇨🇳Tianjin, China
Children's Hospital of Chongqing Medical University
🇨🇳Chongqing, China