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הניסוי הקליני NCT05772871 עבור תסמונת נפרוטית בילדים הוא מגייס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children שלב IV 402
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
ניסוי קליני NCT05772871 מתקיים כדי לבדוק את טיפול עבור תסמונת נפרוטית בילדים. זהו מחקר שלב IV מסוג התערבותי שנמצא כעת במצב מגייס. המחקר התחיל ב-26 באפריל 2023 ומתוכנן לכלול 402 משתתפים. המחקר מנוהל על ידי Jianhua Zhou וצפוי להסתיים ב-30 באוקטובר 2025. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-21 ביוני 2024.
סיכום קצר
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.
תיאור מפורט
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...הצג עוד
כותרת רשמית
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
מצבים רפואיים
תסמונת נפרוטית בילדיםמזהי מחקר נוספים
- HQH-202205
מספר NCT
תחילת המחקר (בפועל)
2023-04-26
עדכון אחרון שפורסם
2024-06-21
סיום המחקר (מוערך)
2025-10-30
משתתפים (מתוכנן)
402
סוג המחקר
התערבותי
שלב
שלב IV
סטטוס
מגייס
מילות מפתח
Huaiqihuang granule
Children
Nephrotic syndrome
Children
Nephrotic syndrome
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיPrednisone, 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...הצג עוד 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...הצג עוד 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. |
פלצבו להשוואהPrednisone, 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...הצג עוד 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...הצג עוד |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
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 |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד, מבוגר
גיל מינימלי למחקר
18 Months
מגדרים מוערכים למחקר
הכל
- 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.הגורם האחראי למחקר
Jianhua Zhou, חוקר נותן החסות, Professor, Tongji Hospital
איש קשר מרכזי למחקר
איש קשר: Jianhua Zhou, Dr., 86+13367266559, [email protected]
26 מיקומי המחקר ב-1 מדינות
Anhui
Anhui Children's Hospital, Hefei, Anhui, China
Fang Deng, איש קשר
מגייס
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Mo Wang, איש קשר
מגייס
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, China
Zihua Yu, איש קשר
מגייס
People's Liberation Army Joint Logistics Force No. 900 Hospital, Fuzhou, Fujian, China
Xiaojing Nie, איש קשר
מגייס
Guangdong
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Xiaoyun Jiang, איש קשר
מגייס
Hebei
Hebei Children's Hospital, Shijiazhuang, Hebei, China
Dongfeng Zhang, איש קשר
מגייס
Heilongjiang
Harbin Children's Hospital, Harbin, Heilongjiang, China
Fang Ning, איש קשר
מגייס
Henan
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Ziming Han, איש קשר
מגייס
Henan Children's Hospital, Zhengzhou, Henan, China
Cuihua Liu, איש קשר
מגייס
The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Jianhua Zhang, איש קשר
מגייס
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Jianhua Zhou, איש קשר
מגייס
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiaowen Wang, איש קשר
מגייס
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
Zhihui Li, איש קשר
מגייס
Jiangsu
Children's Hospital of Soochow University, Suzhou, Jiangsu, China
Xiaozhong Li, איש קשר
מגייס
Jilin
Baiqiu'en First Hospital of Jilin University, Changchun, Jilin, China
Kaishu Zhao, איש קשר
מגייס
Liaoning
Dalian Women and Children's Medical Centre, Dalian, Liaoning, China
Mei Han, איש קשר
מגייס
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Yue Du, איש קשר
מגייס
Shandong
Shandong Provincial Hospital, Jinan, Shandong, China
Shunzhen Sun, איש קשר
מגייס
Shanghai Municipality
Shanghai Children's Hospital, Shanghai, Shanghai Municipality, China
Wenyan Huang, איש קשר
מגייס
Shanxi
Shanxi Children's Hospital, Taiyuan, Shanxi, China
Lijun Zhao, איש קשר
מגייס
Sichuan
West China Second Hospital of Sichuan University, Chengde, Sichuan, China
Yuhong Tao, איש קשר
מגייס
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China
Shipin Feng, איש קשר
מגייס
Tianjin Municipality
Tianjin Children's Hospital, Tianjin, Tianjin Municipality, China
Wenhong Wang, איש קשר
מגייס
Xinjiang
Xinjiang Uiger Municipal People's Hospital, Ürümqi, Xinjiang, China
Feiyan Wang, איש קשר
מגייס
Zhejiang
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, איש קשר
מגייס
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China
Xiaohui Qiao, איש קשר
מגייס