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El ensayo clínico NCT05772871 para Síndrome nefrótico en niños está reclutando. Consulte la vista de tarjeta del Radar de Ensayos Clínicos y las herramientas de descubrimiento de IA para conocer todos los detalles. O haga cualquier pregunta aquí. | ||
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The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children Fase IV 402
Los detalles del ensayo clínico están disponibles principalmente en inglés. ¡Sin embargo, IA Trial Radar puede ayudar! Simplemente haga clic en 'Explicar el estudio' para ver y discutir la información del estudio en el idioma que haya seleccionado.
El ensayo clínico NCT05772871 está diseñado para estudiar el tratamiento de Síndrome nefrótico en niños. Es un estudio intervencionista de Fase IV. Su estado actual es: reclutando. El estudio se inició el 26 de abril de 2023, con el objetivo de reclutar a 402 participantes. Dirigido por Jianhua Zhou, se espera que finalice el 30 de octubre de 2025. Los datos se actualizaron por última vez en ClinicalTrials.gov el 21 de junio de 2024.
Resumen
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.
Descripción detallada
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...Mostrar más
Título oficial
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
Condiciones médicas
Síndrome nefrótico en niñosOtros ID del estudio
- HQH-202205
Número del NCT
Inicio del estudio (real)
2023-04-26
Última actualización
2024-06-21
Fecha de finalización (estimada)
2025-10-30
Inscripción (prevista)
402
Tipo de estudio
Intervencionista
FASE
Fase IV
Estado general
Reclutando
Palabras clave
Huaiqihuang granule
Children
Nephrotic syndrome
Children
Nephrotic syndrome
Objetivo principal
Tratamiento
Método de asignación
Aleatorizado
Modelo de intervención
Paralelo
Enmascaramiento
Cuádruple ciego
Brazos / Intervenciones
| Grupo de participantes | Intervención/Tratamiento |
|---|---|
ExperimentalPrednisone, 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...Mostrar más 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...Mostrar más 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. |
Comparador placeboPrednisone, 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...Mostrar más 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...Mostrar más |
Resultado primario
Resultado secundario
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
| Medida de resultado | Descripción de la medida | Periodo de tiempo |
|---|---|---|
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 |
Asistente de participación
Criterios de elegibilidad
Criterios de edad
Niño, Adulto
Edad mínima
18 Months
Criterios de sexo
Todos
- 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.Parte responsable del estudio
Jianhua Zhou, Investigador-patrocinador, Professor, Tongji Hospital
Contactos centrales del estudio
Contacto: Jianhua Zhou, Dr., 86+13367266559, [email protected]
26 Centros del estudio en 1 países
Anhui
Anhui Children's Hospital, Hefei, Anhui, China
Fang Deng, Contacto
Reclutando
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Mo Wang, Contacto
Reclutando
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, China
Zihua Yu, Contacto
Reclutando
People's Liberation Army Joint Logistics Force No. 900 Hospital, Fuzhou, Fujian, China
Xiaojing Nie, Contacto
Reclutando
Guangdong
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Xiaoyun Jiang, Contacto
Reclutando
Hebei
Hebei Children's Hospital, Shijiazhuang, Hebei, China
Dongfeng Zhang, Contacto
Reclutando
Heilongjiang
Harbin Children's Hospital, Harbin, Heilongjiang, China
Fang Ning, Contacto
Reclutando
Henan
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Ziming Han, Contacto
Reclutando
Henan Children's Hospital, Zhengzhou, Henan, China
Cuihua Liu, Contacto
Reclutando
The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Jianhua Zhang, Contacto
Reclutando
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Jianhua Zhou, Contacto
Reclutando
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiaowen Wang, Contacto
Reclutando
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
Zhihui Li, Contacto
Reclutando
Jiangsu
Children's Hospital of Soochow University, Suzhou, Jiangsu, China
Xiaozhong Li, Contacto
Reclutando
Jilin
Baiqiu'en First Hospital of Jilin University, Changchun, Jilin, China
Kaishu Zhao, Contacto
Reclutando
Liaoning
Dalian Women and Children's Medical Centre, Dalian, Liaoning, China
Mei Han, Contacto
Reclutando
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Yue Du, Contacto
Reclutando
Shandong
Shandong Provincial Hospital, Jinan, Shandong, China
Shunzhen Sun, Contacto
Reclutando
Shanghai Municipality
Shanghai Children's Hospital, Shanghai, Shanghai Municipality, China
Wenyan Huang, Contacto
Reclutando
Shanxi
Shanxi Children's Hospital, Taiyuan, Shanxi, China
Lijun Zhao, Contacto
Reclutando
Sichuan
West China Second Hospital of Sichuan University, Chengde, Sichuan, China
Yuhong Tao, Contacto
Reclutando
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China
Shipin Feng, Contacto
Reclutando
Tianjin Municipality
Tianjin Children's Hospital, Tianjin, Tianjin Municipality, China
Wenhong Wang, Contacto
Reclutando
Xinjiang
Xinjiang Uiger Municipal People's Hospital, Ürümqi, Xinjiang, China
Feiyan Wang, Contacto
Reclutando
Zhejiang
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, Contacto
Reclutando
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China
Xiaohui Qiao, Contacto
Reclutando