رادار التجارب AI | ||
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حالة التجربة السريرية NCT05772871 لـ المتلازمة الكلوية عند الأطفال هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children المرحلة الرابعة ٤٠٢
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT05772871 مصممة لدراسة علاج لـالمتلازمة الكلوية عند الأطفال. إنها تجربة تدخُّلية من المرحلة الرابعة وهي يقبل مشاركين. بدأت في ٦ شوال ١٤٤٤ هـ مع خطة لتجنيد ٤٠٢ مشاركًا. تقودها Jianhua Zhou، ومن المتوقع اكتمالها بحلول ٨ جمادى الأولى ١٤٤٧ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ١٥ ذو الحجة ١٤٤٥ هـ.
الملخص
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.
وصف مفصل
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 successfu...عرض المزيد
العنوان الرسمي
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
الحالات الطبية
المتلازمة الكلوية عند الأطفالمعرّفات دراسة أخرى
- HQH-202205
NCT معرّف
تاريخ البدء (فعلي)
2023-04-26
آخر تحديث مُنشور
2024-06-21
تاريخ الاكتمال (المقدر)
2025-10-30
عدد المشاركين المخطط لهم
٤٠٢
نوع الدراسة
تدخُّلية
المرحلة
المرحلة الرابعة
الحالة
يقبل مشاركين
الكلمات الرئيسية
Huaiqihuang granule
Children
Nephrotic syndrome
Children
Nephrotic syndrome
الغرض الأساسي
العلاج
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
رباعي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةPrednisone, Huaiqihuang granule, and Levamisole placebo In this group, patients will take Prednisone, Huaiqihuang granule, and Levamisole placebo. | Huaiqihuang granule 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 fo...عرض المزيد Prednisone 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 rela...عرض المزيد Levamisole placebo 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. |
مقارن بالدواء الوهميPrednisone, Levamisole, and Huaiqihuang granule placebo In this group, patients will take Prednisone, Levamisole, and Huaiqihuang granule placebo. | Prednisone 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 rela...عرض المزيد Levamisole 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 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, lo...عرض المزيد |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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). | Start of randomization until 6-month follow-up |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Remission time to first relapse | 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 | Among patients who get remission after treatment, number of relapse per patient | Start of randomization until 6-month follow-up |
Relapse rate | Among patients who get remission after treatment, proportion of patients with relapse | 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 | 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. | 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 | 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 | 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 | 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 | 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 | Start of randomization until 6-month follow-up |
Incidence and severity of adverse events (AE) and serious adverse events (SAE) | 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) | Start of randomization until 6-month follow-up |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
طفل, بالغ
العمر الأدنى للدراسة
18 Months
الجنس المؤهل
الكل
- 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.
- 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.
Jianhua ZhouLinkDoc Technology (Beijing) Co. Ltd.الجهة المسؤولة عن الدراسة
Jianhua Zhou, الراعي-المحقق, Professor, Tongji Hospital
جهة اتصال مركزية للدراسة
جهة اتصال: Jianhua Zhou, Dr., 86+13367266559, [email protected]
26 مواقع الدراسة في 1 بلدان
Anhui
Anhui Children's Hospital, Hefei, Anhui, China
Fang Deng, جهة اتصال
يقبل مشاركين
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Mo Wang, جهة اتصال
يقبل مشاركين
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, China
Zihua Yu, جهة اتصال
يقبل مشاركين
People's Liberation Army Joint Logistics Force No. 900 Hospital, Fuzhou, Fujian, China
Xiaojing Nie, جهة اتصال
يقبل مشاركين
Guangdong
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Xiaoyun Jiang, جهة اتصال
يقبل مشاركين
Hebei
Hebei Children's Hospital, Shijiazhuang, Hebei, China
Dongfeng Zhang, جهة اتصال
يقبل مشاركين
Heilongjiang
Harbin Children's Hospital, Harbin, Heilongjiang, China
Fang Ning, جهة اتصال
يقبل مشاركين
Henan
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Ziming Han, جهة اتصال
يقبل مشاركين
Henan Children's Hospital, Zhengzhou, Henan, China
Cuihua Liu, جهة اتصال
يقبل مشاركين
The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Jianhua Zhang, جهة اتصال
يقبل مشاركين
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Jianhua Zhou, جهة اتصال
يقبل مشاركين
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiaowen Wang, جهة اتصال
يقبل مشاركين
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
Zhihui Li, جهة اتصال
يقبل مشاركين
Jiangsu
Children's Hospital of Soochow University, Suzhou, Jiangsu, China
Xiaozhong Li, جهة اتصال
يقبل مشاركين
Jilin
Baiqiu'en First Hospital of Jilin University, Changchun, Jilin, China
Kaishu Zhao, جهة اتصال
يقبل مشاركين
Liaoning
Dalian Women and Children's Medical Centre, Dalian, Liaoning, China
Mei Han, جهة اتصال
يقبل مشاركين
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Yue Du, جهة اتصال
يقبل مشاركين
Shandong
Shandong Provincial Hospital, Jinan, Shandong, China
Shunzhen Sun, جهة اتصال
يقبل مشاركين
Shanghai Municipality
Shanghai Children's Hospital, Shanghai, Shanghai Municipality, China
Wenyan Huang, جهة اتصال
يقبل مشاركين
Shanxi
Shanxi Children's Hospital, Taiyuan, Shanxi, China
Lijun Zhao, جهة اتصال
يقبل مشاركين
Sichuan
West China Second Hospital of Sichuan University, Chengde, Sichuan, China
Yuhong Tao, جهة اتصال
يقبل مشاركين
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China
Shipin Feng, جهة اتصال
يقبل مشاركين
Tianjin Municipality
Tianjin Children's Hospital, Tianjin, Tianjin Municipality, China
Wenhong Wang, جهة اتصال
يقبل مشاركين
Xinjiang
Xinjiang Uiger Municipal People's Hospital, Ürümqi, Xinjiang, China
Feiyan Wang, جهة اتصال
يقبل مشاركين
Zhejiang
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, جهة اتصال
يقبل مشاركين
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China
Xiaohui Qiao, جهة اتصال
يقبل مشاركين