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

Last updated: June 20, 2024
Sponsor: Jianhua Zhou
Overall Status: Active - Recruiting

Phase

4

Condition

Nephropathy

Kidney Failure (Pediatric)

Kidney Disease

Treatment

Huaiqihuang Granule placebo

Huaiqihuang granule

Prednisone

Clinical Study ID

NCT05772871
HQH-202205
  • Ages 18-18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age from 1.5 to 18 years;

  • According to the Evidence-based Guideline for Diagnosis and Treatment ofHormone-sensitive, Relapsed/dependent Nephrotic Syndrome in Children (2016),children diagnosed with PNS;

  • At enrollment, estimated glomerular filtration rate (eGFR)≥90ml/min/1.73m2;

  • At enrollment, serum albumin level below 30g/L, and morning urine protein is 4+ orurinary albumin/creatinine ratio (ACR)≥2.0g/g;

  • Volunteered to participate in this study and signed informed consent. For childrenless than 8 years, legal guardians need to sign the informed consent.

Exclusion

Exclusion Criteria:

  • Children who were diagnosed as steroid-resistant NS;

  • Patients who received Prednisone, other corticosteroids (like Prednisolone,Methylprednisolone), or immunosuppressants (Tacrolimus, Mycophenolate Mofetil,Cyclosporine A, Rituximab, Cyclophosphamide) within 3 months before enrollment;

  • Secondary NS caused by lupus nephritis, hepatitis B associated nephritis, purpuranephritis, and EB virus, cytomegalovirus (CMV), etc;

  • With combined diseases of autoimmune disorder or primary immunodeficiency ormalignancy;

  • With combined diseases of the cardiovascular, liver, hematopoietic system, mentaldisorders, and other serious diseases;

  • With serious infectious diseases (like tuberculosis) in the past or at present;

  • With combined diseases of Human immunodeficiency virus (HIV), hepatitis B and /or Cvirus (HBV, HCV), and other active virus infections;

  • History of diabetes;

  • Abnormal liver function: alanine aminotransferase and aspartate aminotransferaselevels exceed twice the upper limit of the normal range;

  • Participation in other ongoing clinical trials;

  • Other reasons that the researcher considers unsuitable to participate in this study.

Study Design

Total Participants: 402
Treatment Group(s): 5
Primary Treatment: Huaiqihuang Granule placebo
Phase: 4
Study Start date:
April 26, 2023
Estimated Completion Date:
October 30, 2025

Study Description

Nephrotic syndrome (NS) is the most frequent glomerular disease in children, with an incidence of 1.15-16.9 per 100,000 children. Children present with the disease at a median age of 2-3 years, and it is twice as common in boys. More than 90% of children who present with NS respond to corticosteroid treatment, and current practice is to treat most patients empirically with prednisone. However, after initial successful treatment, around 80% of children with steroid sensitive NS have disease relapses requiring further courses of prednisone. About 50% of patients develop frequent relapsing or steroid dependent. Further, the long-term use of corticosteroids is associated with numerous side effects, like obesity, diabetes and hypertension.

Traditional Chinese medicine plays a unique role in the enhancement of immune function and kidney function. Huaiqihuang granule is composed of Trametes robiniophila Murr, Fructus Lycii, and Polygonatum sibiricum. It has been used for the treatment of primary nephrotic syndrome (PNS) in China. Previous studies showed Huaiqihuang granule combined with corticosteroids could significantly decrease relapse and infection rates of PNS and were well tolerated by children. This non-inferiority study aims to compare the efficacy of Prednisone combined with Huaiqihuang Granule against Prednisone combined with Levamisole in the treatment of PNS in children.

In this study, about 20 research centers will participate. A total of 402 participants will be divided into two groups (the intervention group and control group) at a ratio of 1:1. The intervention group will receive Prednisone, Huaiqihuang granule and Levamisole placebo, and the control group will receive Prednisone, Levamisole and Huaiqihuang granule placebo. The planned length of patient recruitment enrolment will be 2 years and the total length of visits be 6 months. After enrollment, participants will be followed up until the end of the study (6 months), second relapse, develop as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or die, whichever occurs first.

Connect with a study center

  • Anhui Children's Hospital

    Hefei, Anhui
    China

    Active - Recruiting

  • Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing
    China

    Active - Recruiting

  • Fujian Children's Hospital

    Fuzhou, Fujian
    China

    Active - Recruiting

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

    Fuzhou, Fujian
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong
    China

    Active - Recruiting

  • Hebei Children's Hospital

    Shijiazhuang, Hebei
    China

    Active - Recruiting

  • Harbin Children's Hospital

    Harbin, Heilongjiang
    China

    Active - Recruiting

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang, Henan
    China

    Active - Recruiting

  • Henan Children's Hospital

    Zhengzhou, Henan
    China

    Active - Recruiting

  • The First Affliated Hospital of Zhengzhou University

    Zhengzhou, Henan
    China

    Active - Recruiting

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

    Wuhan, Hubei
    China

    Active - Recruiting

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

    Wuhan, Hubei
    China

    Active - Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan
    China

    Active - Recruiting

  • Children's Hospital of Soochow University

    Suzhou, Jiangsu
    China

    Active - Recruiting

  • Baiqiu'en First Hospital of Jilin University

    Changchun, Jilin
    China

    Active - Recruiting

  • Dalian Women and Children's Medical Centre

    Dalian, Liaoning
    China

    Active - Recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning
    China

    Active - Recruiting

  • Shandong Provincial Hospital

    Jinan, Shandong
    China

    Active - Recruiting

  • Shanghai Children's Hospital

    Shanghai, Shanghai
    China

    Active - Recruiting

  • Shanxi Children's Hospital

    Taiyuan, Shanxi
    China

    Active - Recruiting

  • West China Second Hospital of Sichuan University

    Chengde, Sichuan
    China

    Active - Recruiting

  • Chengdu Women's and Children's Central Hospital

    Chengdu, Sichuan
    China

    Active - Recruiting

  • Tianjin Children's Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Xinjiang Uiger Municipal People's Hospital

    Ürümqi, Xinjiang
    China

    Active - Recruiting

  • Children's Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang
    China

    Active - Recruiting

  • Ningbo Women's and Children's Hospital

    Ningbo, Zhejiang
    China

    Active - Recruiting

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