A Phase 4 interventional study of Huaiqihuang granule and Prednisone in Nephrotic Syndrome in Children, sponsored by Jianhua Zhou. Recruiting at 26 sites in China. Open to participants aged 18 Months to 18 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Jianhua Zhou · Phase 4, Interventional, and Treatment
Among 34 studies in Nephrotic Syndrome with a site in China — 19 open to participants now, 21 under way, 5 of them phase 3. Nephrotic Syndrome · China.
Among the 34 studies in Nephrotic Syndrome with a site in China, this one has the largest planned enrollment of the 25 interventional ones that give a count, is one of 6 that started in 2023, is one of 3 in phase 4, reaches primary completion later than 1 of the 20 other live ones, and was the 15th registered.
191 studies on the registry are indexed under Nephrotic Syndrome; 65 are open to participants now.
Browse Nephrotic Syndrome studies →19 of the 34 studies in Nephrotic Syndrome with a site in China are open now. Recruiting first, the newest first:
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
Mao Jianhua · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 50 Nephrotic Syndrome studies recruiting now, 23 (46%) set no upper age limit and 22 (44%) stop at 75 or younger; 37 take children under 18; 4 take healthy volunteers.
This study: 18 Months to 18 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
34 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 6 started in 2023.
This study's planned enrollment of 402 is above the median of 46 across 122 interventional studies indexed under Nephrotic Syndrome.
Median enrollment 36 across the 25 interventional studies, 300 across the 9 observational. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 34 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Jianhua Zhou as lead sponsor.
Jianhua Zhou has 1 study filed under Nephrotic Syndrome — fewer than ten, so there is no comparison to draw.
2 of the studies in Nephrotic Syndrome with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07612592Children's Hospital of Chongqing Medical UniversityThe Clinical Application Study of Obinutuzumab in Pediatric Refractory Nephrotic Syndrome | 2026-12-01 |
| NCT06161701Zhejiang Provincial People's HospitalSteroid Diabetes in Patients With Kidney Disease | 2026-12-31 |
Among the 34 studies in Nephrotic Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo.
Drug: Huaiqihuang granule · Drug: Prednisone · Drug: Levamisole placebo
In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo.
Drug: Prednisone · Drug: Levamisole · Drug: Huaiqihuang Granule 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.
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.
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).
Time frame: Start of randomization until 6-month follow-up
Remission time to first relapse
Among patients who get remission after treatment, time from the onset of remission to the first relapse
Time frame: 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
Time frame: Start of randomization until 6-month follow-up
Relapse rate
Among patients who get remission after treatment, proportion of patients with relapse
Time frame: 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
Time frame: 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.
Time frame: 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
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
The level change of serum creatinine, eGFR between baseline and the last testing result during follow-up
Time frame: 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
Time frame: 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
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
The level change of 24h urinary protein (applying to more than 3 years patients) between baseline and the last testing result during follow-up
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
Change in blood pressure before and after treatment
The level change of blood pressure before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in height before and after treatment
The level change of height before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in body weight before and after treatment
The level change of body weight before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in BMI before and after treatment
The level change of BMI before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in serum cholesterol before and after treatment
The level change of serum cholesterol before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in serum triglycerides before and after treatment
The level change of serum triglycerides before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in serum immunoglobulin before and after treatment
The level change of serum immunoglobulin before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in cortisolv (collecting at 8 am) before and after treatment
The level change of cortisolv (collecting at 8 am) before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in serum 25-hydroxyvitamin D before and after treatment
The level change of serum 25-hydroxyvitamin D before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in T cell subtypes before and after treatment
The level change of T cell subtypes before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in the nephronectin before and after treatment
The level change of nephronectin before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in the caveolin-1 before and after treatment
The level change of caveolin-1 before and after treatment
Time frame: Start of randomization until 6-month follow-up
Change in the heparanase before and after treatment
The level change of heparanase before and after treatment
Time frame: Start of randomization until 6-month follow-up
The mutation ratio of single nucleotide polymorphism (SNP) in children and their parents at enrollment.
The testing SNP including rs 2285450, rs 2073901, rs 3129888, rs 4979462 and et al.
Time frame: At enrollment until randomization.
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Sep 2025, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
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