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.
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;
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;
Parallel
Huaiqihuang granule
DrugHuaiqihuang 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
DrugPrednisone, 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
DrugLevamisole 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
DrugLevamisole, 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
DrugHuaiqihuang 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).
Remission time to first relapse
Among patients who get remission after treatment, time from the onset of remission to the first relapse
Number of relapses
Among patients who get remission after treatment, number of relapse per patient
Relapse rate
Among patients who get remission after treatment, proportion of patients with relapse
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
Change in blood pressure before and after treatment
The level change of blood pressure before and after treatment
Change in height before and after treatment
The level change of height before and after treatment
Change in body weight before and after treatment
The level change of body weight before and after treatment
Change in BMI before and after treatment
The level change of BMI before and after treatment
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Jianhua Zhou
Lead sponsor
Tongji Hospital
Sponsor institution
LinkDoc Technology (Beijing) Co. Ltd.
Collaborator
