The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Nephrotic Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observational 1<br>Huaiqihuang Granule | |
| Observational 2<br>Standard treatment+Huaiqihuang Granule | |
| Observational 3<br>Standard treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Huaiqihuang granule, primary nephrotic syndrome, multisite, prospective, open-label