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Die klinische Studie NCT06125405 (STERN) für Nephrotisches Syndrom bei Kindern, Telitacicept 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 the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome (STERN) Phase 3 20 Pädiatrisch
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 NCT06125405 (STERN) untersucht Behandlung im Zusammenhang mit Nephrotisches Syndrom bei Kindern, Telitacicept. Diese interventionsstudie der Phase 3 hat den Status offene rekrutierung und startete am 28. November 2023. Es ist geplant, 20 Teilnehmer aufzunehmen. Durchgeführt von The Children's Hospital of Zhejiang University School of Medicine wird der Abschluss für 24. Oktober 2027 erwartet. Die Daten von ClinicalTrials.gov wurden zuletzt am 21. August 2024 aktualisiert.
Kurzbeschreibung
The main objective is to evaluate the effectiveness of telitacicept in pediatric patients with frequently relapsing or steroid dependent nephrotic syndrome within the 52-week follow-up.
Ausführliche Beschreibung
Nephrotic syndrome(NS) is the most common glomerular disease in children. Approximately 45-50% of patients with nephrotic syndrome exhibit frequent relapses or are dependent on steroid therapy. Frequent relapses or steroid dependence in nephrotic syndrome have been challenging issues for clinicians. Long-term, repeated, and high-dose oral steroid use can lead to side effects such as obesity, delayed development, hype...Mehr anzeigen
Offizieller Titel
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Erkrankungen
Nephrotisches Syndrom bei KindernTelitaciceptPublikationen
Wissenschaftliche Artikel und Forschungspapiere zu dieser klinischen Studie:Weitere Studien-IDs
- STERN
NCT-Nummer
Studienbeginn (tatsächlich)
2023-11-28
Zuletzt aktualisiert
2024-08-21
Studienende (vorauss.)
2027-10-24
Geplante Rekrutierung
20
Studientyp
Interventionsstudie
PHASE
Phase 3
Status
Offene Rekrutierung
Stichwörter
Telitacicept
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
| Teilnehmergruppe/Studienarm | Intervention/Behandlung |
|---|---|
ExperimentellTelitacicept group Weekly administration (administration time can be within 1 week + 3 days). Body weight and dosage: for subjects with body weight greater than 10kg and less than or equal to 20kg, the dose of Telitacicept is 40mg; for subjects with body weight greater than 20kg and less than or equal to 40kg, the dose of Telitacicept is 80mg; for subjects with body weight greater than 40kg and less than or equal to 60kg, the dose of T...Mehr anzeigen | Telitacicept The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks. |
Hauptergebnismessungen
Nebenergebnismessungen
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
1-year relapse-free survival rate | The rate of no relapse within 1 year | 1-year period after enrollment |
| Ergebnismessung | Beschreibung der Messung | Zeitrahmen |
|---|---|---|
Relapse of nephrotic syndrome during 12 months after enrollment | Proportion of patients with one or more relapse(s) of nephrotic syndrome | 1-year period after enrollment |
Number of relapses during 12 months follow up | Number of nephrotic syndrome relapses per patient year during the 12 months period after enrollment | 1-year period after enrollment |
The first time to relapse | The first time to relapse after patients taking part in this study | 1-year period after enrollment |
Cumulative prednisone dosage (milligrams per kilogram per year) | The total dosage of prednisones from the beginning to the end of the trial | 1-year period after enrollment |
Change in hemoglobin of the patients | The changes of hemoglobin (g/L) in each follow-up during the study | 1-year period after enrollment |
Change in blood albumin of the patients | The changes of blood albumin (g/L）in each follow-up during the study | 1-year period after enrollment |
Change in renal function of the patients | The change for renal function was judged by the changes of estimated glomerular filtration rate (eGFR in ml/min/1.73m\^2) in each follow-up during the study | 1-year period after enrollment |
Change in mass index (BMI) during 12-month period after enrollment | Changes in standard deviation scores for weight (Wt in kilograms), height (Ht in meters) will be combined to report body mass index (BMI in kg/m\^2) during 12-month period after enrollment | 1-year period after enrollment |
Teilnahme-Assistent
Eignungskriterien
Zugelassene Altersgruppen
Kind, Erwachsene
Mindestalter
2 Years
Zugelassene Geschlechter
Alle
- Sensitive but frequent relapses or steroids dependence nephrotic syndrome
- Age: 2 to 18 years old
- Normal renal function: estimated glomerular filtration rate ≥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
- No rituximab was used within 6 months, no tacrolimus, mycophenolate mofetil, cyclosporine A, or cyclophosphamide was used within 3 months, no ACTH was used within 3 months prior to the enrollment
- Family history of nephrotic syndrome, chronic glomerulonephritis or uremia
- Leukopenia (White Blood Cells ≤ 3.0 * 10^9 / L)
- Moderate to severe anemia (hemoglobin <9.0 g/dL)
- Thrombocytopenia (platelet count <100*10^12/L)
- Positive Hepatitis B virus serological indicators (Hepatitis B surface antigen or / and Hepatitis B virus e antigen or / and Hepatitis B core antibody), Hepatitis C virus-positive or patients with abnormal liver function (2 or more times of alamine aminotransferase or total bilirubin was exceeded the normal value, and continued to rise for 2 weeks)
- There are chronic active infections such as Epstein-Barrvirus, cytomegalovirus or Mycobacterium tuberculosis, and the usage of steroids and immunosuppressive agents may aggravate the state of an illness
- Secondary nephrotic syndrome (such as purpuric nephritis, lupus nephritis, etc.)
- Those who with hematological or endocrine system diseases as well as serious organs illness such as heart, liver or kidney
- Those who with other autoimmune diseases or primary immunodeficiencies or tumors
- Those who have participated in other clinical trials within three months prior to the enrollment
- Those who was not suitable for participating this study judged by investigator
The Children's Hospital of Zhejiang University School of MedicineVerantwortliche Partei
Mao Jianhua, Hauptprüfer, Professor, The Children's Hospital of Zhejiang University School of Medicine
Zentrale Studienkontakte
Kontakt: Jianhua Mao, MD, 86057186670015, [email protected]
Kontakt: Chunyue Feng, [email protected]
1 Studienstandorte in 1 Ländern
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, MD, Kontakt, 13616819071, [email protected]
Offene Rekrutierung