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Die klinische Studie NCT06079788 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
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial. Phase 3 140 Randomisiert Offene Studie
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Die klinische Studie NCT06079788 untersucht Behandlung im Zusammenhang mit Nephrotisches Syndrom bei Kindern. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 1. November 2023. Es ist geplant, 140 Teilnehmer aufzunehmen. Durchgeführt von Mao Jianhua wird der Abschluss für 31. Dezember 2026 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 12. Oktober 2023 aktualisiert.
Kurzbeschreibung
Primary nephrotic syndrome accounts for approximately 90% of the total number of nephrotic syndrome in childhood and it is the most common glomerular disease in children. Although treatment with steroids is useful for primary nephrotic syndrome, proving to cause frequent relapse/steroid-dependent nephrotic syndrome after treatment and the usage of immunosuppressive agents has become a new choice for the treatment of ...Mehr anzeigen
Ausführliche Beschreibung
Although steroids are recognized as first-line treatments for nephrotic syndrome, the vast majority of children relapse, and about half of them have frequent relapse or steroids dependence after treatment with steroids alone. Some children experienced steroids-resistance after multiple relapses, and eventually developed into chronic kidney dysfunction. Long-term or repeated application of large doses of steroids will...Mehr anzeigen
Offizieller Titel
Study of Adrenocorticotropic Hormone on Children With Frequent Relapse or Steroid-dependent Nephrotic Syndrome: a Prospective, Multicenter, Randomized，Open-label Clinical Trial.
Erkrankungen
Nephrotisches Syndrom bei KindernPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- STAIR
NCT-Nummer
Studienbeginn (tatsächlich)
2023-11-01
Zuletzt aktualisiert
2023-10-12
Studienende (vorauss.)
2026-12-31
Geplante Rekrutierung
140
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Nephrotic Syndrome
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Adrenocorticotropic Hormone
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Adrenocorticotropic Hormone
Primäres Ziel
Behandlung
Zuteilungsmethode
Randomisiert
Interventionsmodell
Parallel
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellAdrenocorticotrophic Hormone Group ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks.
Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd | Adrenocorticotrophic Hormone For patients in complete remission, ACTH is given at a prednisone dose of 1.5-2mg/kg qod or 0.75-1mg/kg qd. ACTH 2 IU/kg/ day, qd,（the maximum dose ≤ 50 IU）, 28 days of continuous use for 5 days， for 24 weeks.
Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks.If stable, taper to 5mg qod (body surface area \> 1.0m2) a...Mehr anzeigen |
Aktives VergleichspräparatSteroid Group Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg （qod） or 0.125mg/kg （qd） every 4 weeks. | Steroid For patients in complete remission, Prednisone: 5mg；Oral tablets; 1.5-2 mg/kg, qod or 0.75-1mg/kg/day,qd, then gradually taper the steroid by 0.25mg/kg qod or 0.125mg/kg qd every 4 weeks. If stable, taper to 5mg qod (body surface area \> 1.0m2) and 2.5mg qod (body surface area \< 1.0m2) and maintain the dose until study completion. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Recurrence-free survival time(day) within 48 weeks | Recurrence-free survival time(day) within 48 weeks | Within 48 weeks after randomization |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Number of relapses during 48 weeks follow up | Number of nephrotic syndrome relapses per patient year during the 48 weeks after randomization | Within 48 weeks after randomization |
The first time to relapse | The first time to relapse after patients taking part in this study | Within 48 weeks after randomization |
Cumulative prednisone dosage (milligrams per kilogram per year) | The total dosage of prednisones from the beginning to the end of the trial | Within 48 weeks after randomization |
Change in renal function of the patients | The change for renal function was judged by the changes of serum creatinine and estimated glomerular filtration rate in each follow-up during the study | Within 48 weeks after randomization |
Change in anthropometry and growth velocity during 48 weeks after randomization | Changes in standard deviation scores for weight, height and body mass index during 48 weeks after randomization | Within 48 weeks after randomization |
Change in serum cholesterol, hemoglobin and blood albumin of the patients | The changes of serum cholesterol, hemoglobin and blood albumin in each follow-up during the study | Within 48 weeks after randomization |
Incidence of infection | The incidence of infection during the study | Within 48 weeks after randomization |
Adverse event | The number of harmful reactions and the types of adverse events during the study | Within 48 weeks after randomization |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
- Age 2-14 years old;
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- No severe hormonal side effects and/or low-dose steroids dependent idiopathic nephrotic syndrome in children (defined as two relapses with an average dose < 0.5mg/kg/day or equivalent alternate-day dose)
- Normal renal function: eGFR≥90ml/min/1.73m2;
- Morning urine protein <1+ or urine protein-creatinine ratio <0.2g/g (<20 mg/mmol) for 3 consecutive days and above when in enroll;
- Prednisone dose was 1.5-2 mg/kg per day before admission;
- No use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months.
- Family history of nephrotic syndrome, chronic glomerulonephritis, uremia and other kidney diseases;
- Patients with congenital or acquired immunodeficiency, or with active tuberculosis, active CMV, EBV, hepatitis B, hepatitis C, HIV infection, deep fungal infection, or other active infections;
- Recurrent or persistent hypertension;
- Secondary nephrotic syndrome, such as nephrotic syndrome secondary to systemic lupus erythematosus, diabetes, drug poisoning and infection;
- Combined with other kidney diseases, such as polycystic kidney, ANCA vasculitis, urinary system malformations, etc.;
- Patients with hypertension, diabetes, tuberculosis, suppurative or fungal infection, gastric and duodenal ulcer disease and heart failure; Patients with other serious heart, liver and other important organs, blood system, endocrine system and other system lesions;
- Co-occurrence of other monogenic genetic diseases known to affect the condition of nephrotic syndrome;
- Patients with serious autoimmune diseases or tumors;
- Use of other immunosuppressants (such as tacrolimus, mortecophenolate, cyclosporin A, cyclophosphamide, levamisole, imidazole ribin, or tripterygium, etc.) within 3 months, and no use of rituximab or beliumab within 6 months;
- Patients who are known to be allergic to ACTH, glucocorticoids, or any of the components of these drugs, and patients with severe hormone-related side effects
- History of organ transplantation (excluding corneal and hair transplantation);
- Patients who had participated in other clinical trials within three months prior to enrollment;
- Any patient whom the investigator determines is not suitable for inclusion in the trial.
Mao Jianhua- 🏥Tongji Hospital
Verantwortliche Partei
Mao Jianhua, Prüfsponsor, professor, The Children's Hospital of Zhejiang University School of Medicine
Zentrale Studienkontakte
Kontakt: jianhua Mao, MD, 0571-87061007, [email protected]
Kontakt: yi Xie, [email protected]
8 Studienstandorte in 1 Ländern
Hubei
Tongji Hospital, Wuhan, Hubei, 430030, China
Jianhua Zhou, MD, Kontakt
Jianhua Zhou, MD, Hauptprüfer
Offene Rekrutierung
Jiangsu
Nanjing Children's Hospital, Nanjing, Jiangsu, 210008, China
Fei Zhao, MD, Kontakt
Fei Zhao, MD, Hauptprüfer
Offene Rekrutierung
Yunnan
Kunming Children's Hospital, Kunming, Yunnan, 650000, China
bo Zhao, MD, Kontakt
Offene Rekrutierung
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Mao Jianhua, MD, Kontakt, 13616819071, [email protected]
Offene Rekrutierung
Ningbo Women & Children's Hospital, Ningbo, Zhejiang, 315000, China
huaqiao Qiao, MD, Kontakt
Offene Rekrutierung
Yuying Childrens Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, 325000, China
xuan de Wang, MD, Kontakt
Offene Rekrutierung
Children's Hospital affiliated to Capital Institute of Pediatrics, Beijing, 100000, China
chaoying chen, MD, Kontakt
Offene Rekrutierung
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, 200000, China
guimei Guo, MD, Kontakt
Offene Rekrutierung