Actively Recruiting

Phase 4
Age: 18Months - 18Years
All Genders
NCT05772871

The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children

Led by Jianhua Zhou · Updated on 2024-06-21

402

Participants Needed

26

Research Sites

131 weeks

Total Duration

On this page

Sponsors

J

Jianhua Zhou

Lead Sponsor

L

LinkDoc Technology (Beijing) Co. Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of primary nephrotic syndrome (PNS) in children.

CONDITIONS

Official Title

The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children

Who Can Participate

Age: 18Months - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from 1.5 to 18 years
  • Diagnosed with primary nephrotic syndrome according to 2016 evidence-based guidelines
  • Estimated glomerular filtration rate (eGFR) of 90 ml/min/1.73m2 or higher at enrollment
  • Serum albumin level below 30 g/L and morning urine protein of 4+ or urinary albumin/creatinine ratio of 2.0 g/g or higher at enrollment
  • Volunteered to participate and signed informed consent; legal guardians sign for children under 8 years old
Not Eligible

You will not qualify if you...

  • Diagnosed with steroid-resistant nephrotic syndrome
  • Received Prednisone, other corticosteroids, or immunosuppressants within 3 months before enrollment
  • Secondary nephrotic syndrome caused by lupus nephritis, hepatitis B nephritis, purpura nephritis, or infections like EB virus or cytomegalovirus
  • Presence of autoimmune disorders, primary immunodeficiency, or cancer
  • Serious diseases involving cardiovascular, liver, hematopoietic, mental health, or other major systems
  • History or current serious infections such as tuberculosis
  • Active viral infections including HIV, hepatitis B or C
  • History of diabetes
  • Abnormal liver function with enzyme levels exceeding twice the upper normal limit
  • Participation in other ongoing clinical trials
  • Any other condition considered unsuitable by the researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 26 locations

1

Anhui Children's Hospital

Hefei, Anhui, China

Actively Recruiting

2

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

3

Fujian Children's Hospital

Fuzhou, Fujian, China

Actively Recruiting

4

People's Liberation Army Joint Logistics Force No. 900 Hospital

Fuzhou, Fujian, China

Actively Recruiting

5

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

6

Hebei Children's Hospital

Shijiazhuang, Hebei, China

Actively Recruiting

7

Harbin Children's Hospital

Harbin, Heilongjiang, China

Actively Recruiting

8

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Actively Recruiting

9

Henan Children's Hospital

Zhengzhou, Henan, China

Actively Recruiting

10

The First Affliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

11

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

12

Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Actively Recruiting

13

Hunan Children's Hospital

Changsha, Hunan, China

Actively Recruiting

14

Children's Hospital of Soochow University

Suzhou, Jiangsu, China

Actively Recruiting

15

Baiqiu'en First Hospital of Jilin University

Changchun, Jilin, China

Actively Recruiting

16

Dalian Women and Children's Medical Centre

Dalian, Liaoning, China

Actively Recruiting

17

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Actively Recruiting

18

Shandong Provincial Hospital

Jinan, Shandong, China

Actively Recruiting

19

Shanghai Children's Hospital

Shanghai, Shanghai Municipality, China

Actively Recruiting

20

Shanxi Children's Hospital

Taiyuan, Shanxi, China

Actively Recruiting

21

West China Second Hospital of Sichuan University

Chengde, Sichuan, China

Actively Recruiting

22

Chengdu Women's and Children's Central Hospital

Chengdu, Sichuan, China

Actively Recruiting

23

Tianjin Children's Hospital

Tianjin, Tianjin Municipality, China

Actively Recruiting

24

Xinjiang Uiger Municipal People's Hospital

Ürümqi, Xinjiang, China

Actively Recruiting

25

Children's Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

26

Ningbo Women's and Children's Hospital

Ningbo, Zhejiang, China

Actively Recruiting

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Research Team

J

Jianhua Zhou, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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