The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Nephrotic Syndrome Clinical Trial

Official title:

A Real-world Study to Evaluate the Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332420
• Other study ID #: HQH-201705
• Status: Completed
• Start date: November 16, 2017
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2022
• Source: Qidong Gaitianli Medicines Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: August 31, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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)?. Hormone-sensitive, relapsed/dependent nephrotic syndrome diagnostic and evidence-based guidelines; ?.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.

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Children's Hospital Capital Institute Of Pediatrics	Beijing	Beijing
China	The first Bethune Hospital of Jilin University	Changchun	Jilin
China	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan
China	Children's Hospital of Chongqing Medical University	Chongqing
China	Harbin Children's Hospital	Harbin	Heilongjiang
China	Jiangxi Provincal Children's Hospital	Nanchang	Jiangxi
China	Benq Medical Center	Nanjing	Jiangsu
China	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu
China	Children's Hospital of Soochow University	Suzhou	Jiangsu
China	Children's Hospital of Shanxi	Taiyuan	Shanxi
China	Tianjin Children's Hospital	Tianjin
China	Urumqi first people's Hospital	Ürümqi	Xinjiang
China	The First Affiliated Hospital of Xinxiang Medical University	Weihui	Henan
China	Wuxi Children's Hospital	Wuxi	Jiangsu
China	Xuzhou Children's Hospital	Xuzhou	Jiangsu
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	Henan Children's Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Qidong Gaitianli Medicines Co., Ltd	Capital Institute of Pediatrics, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of positive urine protein test changing to the negative result	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.	48 weeks after treatment
Primary	The ratio of positive to negative urine protein	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.	48 Weeks after treatment
Primary	The decrease of 24-hour urine protein level	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.	48 Weeks after treatment
Secondary	Recovery of blood albumin levels	Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks.	48 Weeks after treatment
Secondary	Recurrence rate of PNS	The proportion of recurrent subjects to the total number of subjects.	48 Weeks after treatment
Secondary	Rates of infectious complications of PNS	The proportion of complicated infectious subjects to the total number of subjects.	48 Weeks after treatment