The Efficacy of Huaiqihuang Granule in Children With Primary Nephrotic Syndrome

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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Actual): 1507

Contacts and Locations

Study Locations

• China
  • Chongqing, China
    • Children's Hospital of Chongqing Medical University
  • Tianjin, China
    • Tianjin Children's Hospital
  • Beijing
    • Beijing, Beijing, China, 100020
      • Children's Hospital Capital Institute of Pediatrics
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Harbin Children's Hospital
  • Henan
    • Weihui, Henan, China
      • The First Affiliated Hospital of Xinxiang Medical University
    • Zhengzhou, Henan, China
      • Henan Children's Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • BenQ Medical Center
    • Nanjing, Jiangsu, China
      • Children's Hospital of Nanjing Medical University
    • Suzhou, Jiangsu, China
      • Children's Hospital of Soochow University
    • Wuxi, Jiangsu, China
      • Wuxi Children's Hospital
    • Xuzhou, Jiangsu, China
      • Xuzhou Children's Hospital
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Jiangxi Provincal Children's Hospital
  • Jilin
    • Changchun, Jilin, China
      • The First Bethune Hospital of Jilin University
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shanxi
    • Taiyuan, Shanxi, China
      • Children's Hospital of Shanxi
  • Sichuan
    • Chengdu, Sichuan, China
      • Chengdu Women's and Children's central hospital
  • Xinjiang
    • Ürümqi, Xinjiang, China
      • Urumqi first people's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children are diagnosed with primary nephrotic syndrome

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Observational 1; Huaiqihuang Granule
Observational 2; Standard treatment+Huaiqihuang Granule
Observational 3; Standard treatment

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Qidong Gaitianli Medicines Co., Ltd
• Collaborators: Capital Institute of Pediatrics, China
• Investigators: Principal Investigator: Chaoying Chen, Professor, Children's Hospital of The Capital Institute of Pediatrics

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: November 1, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: open-label; prospective; primary nephrotic syndrome; multisite; Huaiqihuang granule
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease; Syndrome; Nephrotic Syndrome; Nephrosis
• Other Study ID Numbers: HQH-201705

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No