- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05772871
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
Compare the Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule Versus Combined With Levamisole for Primary Nephrotic Syndrome in Children: A Prospective, Multi-center, Randomized, Double-blind, Non-inferiority Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jianhua Zhou, Dr.
- Phone Number: 86+13367266559
- Email: jhzhou@tjh.tjmu.edu.cn
Study Locations
-
-
Fujian
-
Fuzhou, Fujian, China
- Recruiting
- Fujian Children's Hospital
-
Contact:
- Zihua Yu
-
-
Guangdong
-
Guangzhou, Guangdong, China
- Recruiting
- The First Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Xiaoyun Jiang
-
-
Henan
-
Xinxiang, Henan, China
- Recruiting
- The First Affiliated Hospital of Xinxiang Medical University
-
Contact:
- Ziming Han
-
Zhengzhou, Henan, China
- Recruiting
- Henan Children's Hospital
-
Contact:
- Cuihua Liu
-
Zhengzhou, Henan, China
- Recruiting
- The First Affliated Hospital of Zhengzhou University
-
Contact:
- Jianhua Zhang
-
-
Hubei
-
Wuhan, Hubei, China
- Recruiting
- Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
-
Contact:
- Jianhua Zhou
-
-
Hunan
-
Changsha, Hunan, China
- Recruiting
- Hunan Children's Hospital
-
Contact:
- Zhihui Li
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- Chengdu Women's and Children's Central Hospital
-
Contact:
- Shipin Feng
-
-
Xinjiang
-
Ürümqi, Xinjiang, China
- Recruiting
- Xinjiang Uiger Municipal People's Hospital
-
Contact:
- Feiyan Wang
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age from 1.5 to 18 years;
- According to the Evidence-based Guideline for Diagnosis and Treatment of Hormone-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+ or urinary albumin/creatinine ratio (ACR)≥2.0g/g;
- Volunteered to participate in this study and signed informed consent. For children less than 8 years, legal guardians need to sign the informed consent.
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, purpura nephritis, and EB virus, cytomegalovirus (CMV), etc;
- With combined diseases of autoimmune disorder or primary immunodeficiency or malignancy;
- With combined diseases of the cardiovascular, liver, hematopoietic system, mental disorders, 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 C virus (HBV, HCV), and other active virus infections;
- History of diabetes;
- Abnormal liver function: alanine aminotransferase and aspartate aminotransferase levels 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prednisone, Huaiqihuang granule, and Levamisole placebo
In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo.
|
Huaiqihuang Granule, oral administration, recommended daily dose: for body weight <10 kg, 5g, twice a day; for 10 kg ≤ body weight <20 kg, 10g, twice a day; for 20 kg≤body weight <30 kg, 15g, twice a day; for 30 kg≤body weight <50 kg, 20g, twice a day; for body weight>50 kg, 30g, twice a day.
Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Prednisone, oral administration, recommended dose: 2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks.
If patients have relapsed during reducing dosage or withdrawal, the patients will receive Prednisone for 8 weeks again [2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks].
If a second relapse is observed, patients will receive immunosuppressants and then withdraw from the trial.
Levamisole placebo, 1.25 mg/kg.
once daily.
Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
|
Placebo Comparator: Prednisone, Levamisole, and Huaiqihuang granule placebo
In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo.
|
Prednisone, oral administration, recommended dose: 2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks.
If patients have relapsed during reducing dosage or withdrawal, the patients will receive Prednisone for 8 weeks again [2mg/kg/d (maximum 60 mg/d) for 4 weeks followed by 2 mg/kg (maximum 60mg) on alternate days for the other 4 weeks].
If a second relapse is observed, patients will receive immunosuppressants and then withdraw from the trial.
Levamisole, 1.25 mg/kg.
once daily.
Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
Huaiqihuang Granule placebo, oral administration, recommended daily dose: for body weight <10 kg, 5g, twice a day; for 10 kg ≤ body weight <20 kg, 10g, twice a day; for 20 kg≤body weight <30 kg, 15g, twice a day; for 30 kg≤body weight <50 kg, 20g, twice a day; for body weight>50 kg, 30g, twice a day.
Continuous medication until the end of the study (6 months), second relapse, development as steroid-resistant, lost to follow-up, withdrawal from the study for any reason, or death, whichever occurs first.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maintaining remission rate
Time Frame: Start of randomization until 6-month follow-up
|
At the end of the study, the proportion of patients who maintained urine protein negative without relapse (removed the patients who developed steroid resistance at the first 4 weeks of treatment of Prednisone).
|
Start of randomization until 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission time to first relapse
Time Frame: Start of onset of remission after treatment until first relapse, assessed up to 6-month
|
Among patients who get remission after treatment, time from the onset of remission to the first relapse
|
Start of onset of remission after treatment until first relapse, assessed up to 6-month
|
Number of relapses
Time Frame: Start of randomization until 6-month follow-up
|
Among patients who get remission after treatment, number of relapse per patient
|
Start of randomization until 6-month follow-up
|
Relapse rate
Time Frame: Start of randomization until 6-month follow-up
|
Among patients who get remission after treatment, proportion of patients with relapse
|
Start of randomization until 6-month follow-up
|
Incidence of frequently relapse
Time Frame: Start of randomization until 6-month follow-up
|
Among patients who get remission after treatment, proportion of patients with more than two times of relapses within 6-month follow-up
|
Start of randomization until 6-month follow-up
|
Infection rate
Time Frame: Start of medication until 6-month follow-up
|
Proportion of patients experiencing infection during the treatment.
Infections include respiratory tract infections, urinary tract infections, skin infections, gastrointestinal infections, and others.
|
Start of medication until 6-month follow-up
|
Cumulative corticosteroids dosage adjusted by body weight
Time Frame: Start of receiving corticosteroids until 6-month follow-up
|
Total amount of per patient per kilogram cumulative corticosteroids dosage
|
Start of receiving corticosteroids until 6-month follow-up
|
Change in serum creatinine and estimated glomerular filtration rate (eGFR) before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum creatinine, eGFR between baseline and the last testing result during follow-up
|
Start of randomization until 6-month follow-up
|
Change in serum albumin before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum albumin between baseline and the last testing result during follow-up
|
Start of randomization until 6-month follow-up
|
Change in urinary albumin/creatinine ratio (ACR) before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of urinary albumin/creatinine ratio (ACR) between baseline and the last testing result during follow-up
|
Start of randomization until 6-month follow-up
|
Change in 24h urinary protein (applying to more than 3 years patients) before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of 24h urinary protein (applying to more than 3 years patients) between baseline and the last testing result during follow-up
|
Start of randomization until 6-month follow-up
|
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time Frame: Start of randomization until 6-month follow-up
|
Start of randomization until 6-month follow-up
|
|
Incidence and severity of adverse reactions (ADR), serious adverse reactions (SADR), suspicious and unexpected serious adverse reactions (SUSAR)
Time Frame: Start of randomization until 6-month follow-up
|
Start of randomization until 6-month follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in blood pressure before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of blood pressure before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in height before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of height before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in body weight before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of body weight before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in BMI before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of BMI before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in serum cholesterol before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum cholesterol before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in serum triglycerides before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum triglycerides before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in serum immunoglobulin before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum immunoglobulin before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in cortisolv (collecting at 8 am) before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of cortisolv (collecting at 8 am) before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in serum 25-hydroxyvitamin D before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of serum 25-hydroxyvitamin D before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in T cell subtypes before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of T cell subtypes before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in the nephronectin before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of nephronectin before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in the caveolin-1 before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of caveolin-1 before and after treatment
|
Start of randomization until 6-month follow-up
|
Change in the heparanase before and after treatment
Time Frame: Start of randomization until 6-month follow-up
|
The level change of heparanase before and after treatment
|
Start of randomization until 6-month follow-up
|
The mutation ratio of single nucleotide polymorphism (SNP) in children and their parents at enrollment.
Time Frame: At enrollment until randomization.
|
The testing SNP including rs 2285450, rs 2073901, rs 3129888, rs 4979462 and et al.
|
At enrollment until randomization.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jianhua Zhou, Dr., Tongji Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Kidney Diseases
- Urologic Diseases
- Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Syndrome
- Nephrotic Syndrome
- Nephrosis
- Physiological Effects of Drugs
- Anti-Infective Agents
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Adjuvants, Immunologic
- Antiparasitic Agents
- Antinematodal Agents
- Anthelmintics
- Prednisone
- Levamisole
Other Study ID Numbers
- HQH-202205
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Nephrotic Syndrome in Children
-
University of CalgaryUnknownNephrotic Syndrome in Children | Nephrotic Syndrome, Minimal Change | Nephrotic Syndrome,IdiopathicCanada
-
Fang DengNot yet recruitingEfficacy and Safety of Broncho-Vaxom in the First Episode of Pediatric Idiopathic Nephrotic SyndromeNephrotic Syndrome in Children
-
Fondazione IRCCS Ca' Granda, Ospedale Maggiore...Cell Factory Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Laboratorio...CompletedIdiopathic Nephrotic Syndrome | Nephrotic Syndrome in Children | Steroid-Dependent Nephrotic SyndromeItaly
-
Wayne State UniversityChildren's Hospital of Fudan UniversityTerminatedNephrotic Syndrome in ChildrenChina, United States
-
Mao JianhuaTongji Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine and other collaboratorsRecruiting
-
Maha RadwanAssiut UniversityNot yet recruitingNephrotic Syndrome in Children
-
The Children's Hospital of Zhejiang University...RecruitingNephrotic Syndrome in Children | TelitaciceptChina
-
Children's Hospital of Chongqing Medical UniversityRecruitingNephrotic Syndrome in ChildrenChina
-
The Children's Hospital of Zhejiang University...RecruitingRituximab | Nephrotic Syndrome in ChildrenChina
-
The Children's Hospital of Zhejiang University...Peking University First Hospital; Tongji Hospital; Shandong Provincial Hospital; Children's Hospital of Fudan University and other collaboratorsCompletedNephrotic Syndrome in ChildrenChina
Clinical Trials on Huaiqihuang granule
-
Qidong Gaitianli Medicines Co., LtdHuazhong University of Science and TechnologyActive, not recruitingImmune ThrombocytopeniaChina
-
Henan University of Traditional Chinese MedicineUnknownPulmonary Disease, Chronic Obstructive
-
Korea Health Industry Development InstituteUnknown
-
Henan University of Traditional Chinese MedicineUnknown
-
Shanghai University of Traditional Chinese MedicineLonghua HospitalRecruiting
-
Xiyuan Hospital of China Academy of Chinese Medical...The First Affiliated Hospital of Henan University of Traditional Chinese... and other collaboratorsRecruitingNon-erosive Reflux Disease | Diarrhea-Predominant Irritable Bowel SyndromeChina
-
Xiyuan Hospital of China Academy of Chinese Medical...First Affiliated Hospital of Heilongjiang Chinese Medicine University; Liuzhou... and other collaboratorsRecruitingGastroesophageal Reflux | Functional DysphoniaChina
-
Tasly Pharmaceutical Group Co., LtdUnknownIrritable Bowel Syndrome With DiarrheaChina
-
Heilongjiang Quanle Pharmaceutical Co., Ltd.Not yet recruiting
-
Peking University People's HospitalRecruitingAcute Exacerbation of Chronic Obstructive Pulmonary DiseaseChina