The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Sponsor

Qidong Gaitianli Medicines Co., Ltd (Industry)

Overall Status

Completed

CT.gov ID

NCT03332420

Collaborator

Capital Institute of Pediatrics, China (Other)

1,507

Enrollment

Locations

45.5

Actual Duration (Months)

88.6

Patients Per Site

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

1507 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Nov 16, 2017

Actual Primary Completion Date :

Jul 21, 2021

Actual Study Completion Date :

Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Observational 1 Huaiqihuang Granule
Observational 2 Standard treatment+Huaiqihuang Granule
Observational 3 Standard treatment

Outcome Measures

Primary Outcome Measures

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 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.
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.

Secondary Outcome Measures

Recovery of blood albumin levels [48 Weeks after treatment]
Compared blood albumin levels between baseline and follow-up timepoint, assessed up to 48 weeks.
Recurrence rate of PNS [48 Weeks after treatment]
The proportion of recurrent subjects to the total number of subjects.
Rates of infectious complications of PNS [48 Weeks after treatment]
The proportion of complicated infectious subjects to the total number of subjects.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Capital Institute Of Pediatrics	Beijing	Beijing	China	100020
2	Harbin Children's Hospital	Harbin	Heilongjiang	China
3	The First Affiliated Hospital of Xinxiang Medical University	Weihui	Henan	China
4	Henan Children's Hospital	Zhengzhou	Henan	China
5	Benq Medical Center	Nanjing	Jiangsu	China
6	Children's Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
7	Children's Hospital of Soochow University	Suzhou	Jiangsu	China
8	Wuxi Children's Hospital	Wuxi	Jiangsu	China
9	Xuzhou Children's Hospital	Xuzhou	Jiangsu	China
10	Jiangxi Provincal Children's Hospital	Nanchang	Jiangxi	China
11	The first Bethune Hospital of Jilin University	Changchun	Jilin	China
12	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China
13	Children's Hospital of Shanxi	Taiyuan	Shanxi	China
14	Chengdu Women's and Children's Central Hospital	Chengdu	Sichuan	China
15	Urumqi first people's Hospital	Ürümqi	Xinjiang	China
16	Children's Hospital of Chongqing Medical University	Chongqing		China
17	Tianjin Children's Hospital	Tianjin		China