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Die klinische Studie NCT05772871 für Nephrotisches Syndrom bei Kindern ist offene rekrutierung. In der Kartenansicht des Klinische Studien Radar und den KI-Entdeckungstools finden Sie alle Details. Oder stellen Sie hier Ihre Fragen. | ||
Eine Studie entspricht den Filterkriterien
Kartenansicht
The Efficacy and Safety of Prednisone Combined With Huaiqihuang Granule for Primary Nephrotic Syndrome in Children Phase 4 402
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT05772871 untersucht Behandlung im Zusammenhang mit Nephrotisches Syndrom bei Kindern. Diese interventionsstudie der Phase 4 hat den Status offene rekrutierung und startete am 26. April 2023. Es ist geplant, 402 Teilnehmer aufzunehmen. Durchgeführt von Jianhua Zhou wird der Abschluss für 30. Oktober 2025 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. Juni 2024 aktualisiert.
Kurzbeschreibung
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.
Ausführliche Beschreibung
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...Mehr anzeigen
Offizieller Titel
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
Erkrankungen
Nephrotisches Syndrom bei KindernWeitere Studien-IDs
- HQH-202205
NCT-Nummer
Studienbeginn (tatsächlich)
2023-04-26
Zuletzt aktualisiert
2024-06-21
Studienende (vorauss.)
2025-10-30
Geplante Rekrutierung
402
Studientyp
Interventionsstudie
PHASE
Phase 4
Status
Offene Rekrutierung
Stichwörter
Huaiqihuang granule
Children
Nephrotic syndrome
Children
Nephrotic syndrome
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Vierfach verblindet
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellPrednisone, 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...Mehr anzeigen 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...Mehr anzeigen 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. |
Placebo-VergleichspräparatPrednisone, 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...Mehr anzeigen 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...Mehr anzeigen |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
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 |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
18 Months
Zugelassene Geschlechter
Alle
- 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.Verantwortliche Partei
Jianhua Zhou, Prüfsponsor, Professor, Tongji Hospital
Zentrale Studienkontakte
Kontakt: Jianhua Zhou, Dr., 86+13367266559, [email protected]
26 Studienstandorte in 1 Ländern
Anhui
Anhui Children's Hospital, Hefei, Anhui, China
Fang Deng, Kontakt
Offene Rekrutierung
Chongqing Municipality
Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Mo Wang, Kontakt
Offene Rekrutierung
Fujian
Fujian Children's Hospital, Fuzhou, Fujian, China
Zihua Yu, Kontakt
Offene Rekrutierung
People's Liberation Army Joint Logistics Force No. 900 Hospital, Fuzhou, Fujian, China
Xiaojing Nie, Kontakt
Offene Rekrutierung
Guangdong
The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China
Xiaoyun Jiang, Kontakt
Offene Rekrutierung
Hebei
Hebei Children's Hospital, Shijiazhuang, Hebei, China
Dongfeng Zhang, Kontakt
Offene Rekrutierung
Heilongjiang
Harbin Children's Hospital, Harbin, Heilongjiang, China
Fang Ning, Kontakt
Offene Rekrutierung
Henan
The First Affiliated Hospital of Xinxiang Medical University, Xinxiang, Henan, China
Ziming Han, Kontakt
Offene Rekrutierung
Henan Children's Hospital, Zhengzhou, Henan, China
Cuihua Liu, Kontakt
Offene Rekrutierung
The First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China
Jianhua Zhang, Kontakt
Offene Rekrutierung
Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Jianhua Zhou, Kontakt
Offene Rekrutierung
Wuhan Children's Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Xiaowen Wang, Kontakt
Offene Rekrutierung
Hunan
Hunan Children's Hospital, Changsha, Hunan, China
Zhihui Li, Kontakt
Offene Rekrutierung
Jiangsu
Children's Hospital of Soochow University, Suzhou, Jiangsu, China
Xiaozhong Li, Kontakt
Offene Rekrutierung
Jilin
Baiqiu'en First Hospital of Jilin University, Changchun, Jilin, China
Kaishu Zhao, Kontakt
Offene Rekrutierung
Liaoning
Dalian Women and Children's Medical Centre, Dalian, Liaoning, China
Mei Han, Kontakt
Offene Rekrutierung
Shengjing Hospital of China Medical University, Shenyang, Liaoning, China
Yue Du, Kontakt
Offene Rekrutierung
Shandong
Shandong Provincial Hospital, Jinan, Shandong, China
Shunzhen Sun, Kontakt
Offene Rekrutierung
Shanghai Municipality
Shanghai Children's Hospital, Shanghai, Shanghai Municipality, China
Wenyan Huang, Kontakt
Offene Rekrutierung
Shanxi
Shanxi Children's Hospital, Taiyuan, Shanxi, China
Lijun Zhao, Kontakt
Offene Rekrutierung
Sichuan
West China Second Hospital of Sichuan University, Chengde, Sichuan, China
Yuhong Tao, Kontakt
Offene Rekrutierung
Chengdu Women's and Children's Central Hospital, Chengdu, Sichuan, China
Shipin Feng, Kontakt
Offene Rekrutierung
Tianjin Municipality
Tianjin Children's Hospital, Tianjin, Tianjin Municipality, China
Wenhong Wang, Kontakt
Offene Rekrutierung
Xinjiang
Xinjiang Uiger Municipal People's Hospital, Ürümqi, Xinjiang, China
Feiyan Wang, Kontakt
Offene Rekrutierung
Zhejiang
Children's Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, Kontakt
Offene Rekrutierung
Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China
Xiaohui Qiao, Kontakt
Offene Rekrutierung