Clinical trial NCT03332420: The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
Official title: A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nephrotic Syndrome
Keywords: Huaiqihuang granule
primary nephrotic syndrome
multisite
prospective
open-label
Lead sponsor: Qidong Gaitianli Medicines Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Capital Institute of Pediatrics, China
First posted: 2017-11-06
Enrollment: 1507
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children are diagnosed with primary nephrotic syndrome

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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Age from 1 to18;
3. ALT and AST levels do not exceed twice the upper limit of the normal range;;
4. Provision of written informed consent by legal guardians.

Exclusion Criteria:

1. 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;
2. with combined diseases of cardiovascular, liver, hematopoietic system, mental disorders and other serious diseases;
3. History of diabetes or examinations showed elevated blood glucose levels;
4. Participation in other ongoing clinical trials or during their observation period within the last three months prior to visit 1;
5. Previous/concomitant treatment with any other immunomodulators within the last three months prior to visit 1 ;
6. Patients who are unlikely to adhere to the protocol.

Primary outcomes:
measure: Duration of positive urine protein test changing to the negative result
timeFrame: 48 weeks after treatment
measure: The ratio of positive to negative urine protein
timeFrame: 48 Weeks after treatment
measure: The decrease of 24-hour urine protein level
timeFrame: 48 Weeks after treatment
Secondary outcomes:
measure: Recovery of blood albumin levels
timeFrame: 48 Weeks after treatment
measure: Recurrence rate of PNS
timeFrame: 48 Weeks after treatment
measure: Rates of infectious complications of PNS
timeFrame: 48 Weeks after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Children's Hospital Capital Institute Of Pediatrics
state: Beijing
city: Harbin
country: China
facility: Harbin Children's Hospital
state: Heilongjiang
city: Weihui
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University
state: Henan
city: Zhengzhou
country: China
facility: Henan Children's Hospital
state: Henan
city: Nanjing
country: China
facility: Benq Medical Center
state: Jiangsu
city: Nanjing
country: China
facility: Children's Hospital of Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Children's Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi Children's Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Children's Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Jiangxi Provincal Children's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The first Bethune Hospital of Jilin University
state: Jilin
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Taiyuan
country: China
facility: Children's Hospital of Shanxi
state: Shanxi
city: Chengdu
country: China
facility: Chengdu Women's and Children's Central Hospital
state: Sichuan
city: Ürümqi
country: China
facility: Urumqi first people's Hospital
state: Xinjiang
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
city: Tianjin
country: China
facility: Tianjin Children's Hospital
Study officials:
affiliation: Children's Hospital of The Capital Institute of Pediatrics
name: Chaoying Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: