Nephrotic Syndrome in ChildrenPhase 4NCT05772871
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children
A Phase 4 study testing Huaiqihuang granule, Prednisone and Levamisole in people with Nephrotic Syndrome in Children, run by Jianhua Zhou at 26 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months to 18 years
- Conditions the study is for
- Nephrotic Syndrome in Children
- What is being tested?
- Huaiqihuang granule, Prednisone and Levamisole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 402 participants
- Where
- 26 sitesChina
- Study dates
- 26 Apr 2023to 30 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
China26 sites, 26 recruiting
- Recruiting
Baiqiu'en First Hospital of Jilin University
Changchun, Jilin
Kaishu Zhao
- Recruiting
Hunan Children's Hospital
Changsha, Hunan
Zhihui Li
- Recruiting
West China Second Hospital of Sichuan University
Chengde, Sichuan
Yuhong Tao
- Recruiting
Chengdu Women's and Children's Central Hospital
Chengdu, Sichuan
Shipin Feng
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality
Mo Wang
- Recruiting
Dalian Women and Children's Medical Centre
Dalian, Liaoning
Mei Han
- Recruiting
Fujian Children's Hospital
Fuzhou, Fujian
Zihua Yu
- Recruiting
People's Liberation Army Joint Logistics Force No. 900 Hospital
Fuzhou, Fujian
Xiaojing Nie
- Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Xiaoyun Jiang
- Recruiting
Children's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jianhua Mao
- Recruiting
Harbin Children's Hospital
Harbin, Heilongjiang
Fang Ning
- Recruiting
Anhui Children's Hospital
Hefei, Anhui
Fang Deng
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong
Shunzhen Sun
- Recruiting
Ningbo Women's and Children's Hospital
Ningbo, Zhejiang
Xiaohui Qiao
- Recruiting
Shanghai Children's Hospital
Shanghai, Shanghai Municipality
Wenyan Huang
- Recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Yue Du
- Recruiting
Hebei Children's Hospital
Shijiazhuang, Hebei
Dongfeng Zhang
- Recruiting
Children's Hospital of Soochow University
Suzhou, Jiangsu
Xiaozhong Li
- Recruiting
Shanxi Children's Hospital
Taiyuan, Shanxi
Lijun Zhao
- Recruiting
Tianjin Children's Hospital
Tianjin, Tianjin Municipality
Wenhong Wang
- Recruiting
Xinjiang Uiger Municipal People's Hospital
Ürümqi, Xinjiang
Feiyan Wang
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Jianhua Zhou
- Recruiting
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
Xiaowen Wang
- Recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan
Ziming Han
- Recruiting
Henan Children's Hospital
Zhengzhou, Henan
Cuihua Liu
- Recruiting
The First Affliated Hospital of Zhengzhou University
Zhengzhou, Henan
Jianhua Zhang
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Nephrotic Syndrome in Children
- Being tested
- Huaiqihuang granule, Prednisone, Levamisole placebo, Levamisole, Huaiqihuang Granule placebo
- Keywords
- Huaiqihuang granule, Children, Nephrotic syndrome
- Medical subject headings
- Nephrotic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huaiqihuang granuleDrug
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.
PrednisoneDrug
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 placeboDrug
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.
LevamisoleDrug
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 placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Prednisone, Huaiqihuang granule, and Levamisole placebo | Experimental | In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo. Receives: Drug: Huaiqihuang granule; Drug: Prednisone; Drug: Levamisole placebo |
| Prednisone, Levamisole, and Huaiqihuang granule placebo | Placebo comparator | In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo. Receives: Drug: Prednisone; Drug: Levamisole; Drug: Huaiqihuang Granule placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintaining remission rate
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).
Measured: Start of randomization until 6-month follow-up
Secondary outcomes (12)
Remission time to first relapse
Among patients who get remission after treatment, time from the onset of remission to the first relapse
Measured: Start of onset of remission after treatment until first relapse, assessed up to 6-month
Number of relapses
Among patients who get remission after treatment, number of relapse per patient
Measured: Start of randomization until 6-month follow-up
Relapse rate
Among patients who get remission after treatment, proportion of patients with relapse
Measured: Start of randomization until 6-month follow-up
Incidence of frequently relapse
Among patients who get remission after treatment, proportion of patients with more than two times of relapses within 6-month follow-up
Measured: Start of randomization until 6-month follow-up
Infection rate
Proportion of patients experiencing infection during the treatment. Infections include respiratory tract infections, urinary tract infections, skin infections, gastrointestinal infections, and others.
Measured: Start of medication until 6-month follow-up
Cumulative corticosteroids dosage adjusted by body weight
Total amount of per patient per kilogram cumulative corticosteroids dosage
Measured: Start of receiving corticosteroids until 6-month follow-up
Change in serum creatinine and estimated glomerular filtration rate (eGFR) before and after treatment
The level change of serum creatinine, eGFR between baseline and the last testing result during follow-up
Measured: Start of randomization until 6-month follow-up
Change in serum albumin before and after treatment
The level change of serum albumin between baseline and the last testing result during follow-up
Measured: Start of randomization until 6-month follow-up
Change in urinary albumin/creatinine ratio (ACR) before and after treatment
The level change of urinary albumin/creatinine ratio (ACR) between baseline and the last testing result during follow-up
Measured: Start of randomization until 6-month follow-up
Change in 24h urinary protein (applying to more than 3 years patients) before and after treatment
The level change of 24h urinary protein (applying to more than 3 years patients) between baseline and the last testing result during follow-up
Measured: Start of randomization until 6-month follow-up
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Measured: 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)
Measured: Start of randomization until 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start26 Apr 2023
- Primary completion15 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephrotic Syndrome in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 402 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jianhua Zhou
- Sponsor type
- University, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Responsible party
- Sponsor-investigator, Jianhua Zhou, Tongji Hospital
- Investigators
- Jianhua Zhou, Dr., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772871
- Sponsor's protocol ID
- HQH-202205
- Status last verified
- Jun 2024
- First submitted
- 24 Feb 2023
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05772871
- Acronym / sponsor ID
- HQH-202205
- Conditions
- Nephrotic Syndrome in Children
- Keywords
- Huaiqihuang granule, Children, Nephrotic syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 402 participants (estimated)
- Lead sponsor
- Jianhua ZhouUniversity, hospital or other
- Collaborators
- LinkDoc Technology (Beijing) Co. Ltd.
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisone, Huaiqihuang granule, and Levamisole placebo | Experimental | Drug: Huaiqihuang granule, Drug: Prednisone, Drug: Levamisole placeboIn this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo. |
| Prednisone, Levamisole, and Huaiqihuang granule placebo | Placebo comparator | Drug: Prednisone, Drug: Levamisole, Drug: Huaiqihuang Granule placeboIn this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo. |
Who may qualify
- Ages
- 18 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Huaiqihuang granuleHuaiqihuang 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. | Drug | Prednisone, Huaiqihuang granule, and Levamisole placebo |
| PrednisonePrednisone, 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. | Drug | Prednisone, Huaiqihuang granule, and Levamisole placebo, Prednisone, Levamisole, and Huaiqihuang granule placebo |
| Levamisole placeboLevamisole 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. | Drug | Prednisone, Huaiqihuang granule, and Levamisole placebo |
| LevamisoleLevamisole, 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. | Drug | Prednisone, Levamisole, and Huaiqihuang granule placebo |
| Huaiqihuang Granule placeboHuaiqihuang 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. | Drug | Prednisone, Levamisole, and Huaiqihuang granule placebo |
Primary outcome
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).
12 secondary outcomes
Remission time to first relapse
Time frame: 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
Relapse rate
Time frame: Start of randomization until 6-month follow-up
Incidence of frequently relapse
Time frame: Start of randomization until 6-month follow-up
Infection rate
Time frame: 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
Change in serum creatinine and estimated glomerular filtration rate (eGFR) before and after treatment
Time frame: 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
Change in urinary albumin/creatinine ratio (ACR) before and after treatment
Time frame: 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
Incidence and severity of adverse events (AE) and serious adverse events (SAE)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhua Zhou, Dr. principal investigator
Tongji Hospital
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaiqihuang granule, Prednisone and Levamisole in people with Nephrotic Syndrome in Children, run by Jianhua Zhou at 26 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jianhua Zhou, Dr. (86+13367266559, jhzhou@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maintaining remission rate (time frame: Start of randomization until 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.