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O estudo clínico NCT06125405 (STERN) para Síndrome nefrótica em crianças, Telitacicept está em recrutamento. Consulte a visualização em cartões do Radar de Estudos Clínicos e as ferramentas de descoberta de IA para ver todos os detalhes. Ou pergunte qualquer coisa aqui. | ||
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Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome (STERN) Fase III 20 Pediátrico
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O estudo clínico NCT06125405 (STERN) procura avaliar tratamento para Síndrome nefrótica em crianças, Telitacicept. Este é um estudo intervencionista de Fase III. Seu status atual é: em recrutamento. O estudo começou em 28 de novembro de 2023 e pretende incluir 20 participantes. Coordenado por The Children's Hospital of Zhejiang University School of Medicine e deve ser concluído em 24 de outubro de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 21 de agosto de 2024.
Resumo
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.
Descrição detalhada
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...Mostrar mais
Título oficial
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
Condições médicas
Síndrome nefrótica em criançasTelitaciceptPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:Outros IDs do estudo
- STERN
Número NCT
Data de início (real)
2023-11-28
Última atualização postada
2024-08-21
Data de conclusão (estimada)
2027-10-24
Inscrição (estimada)
20
Tipo de estudo
Intervencionista
FASE
Fase III
Status
Em recrutamento
Palavras-chave
Telitacicept
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Propósito principal
Tratamento
Alocação do design
N/A
Modelo de intervenção
Grupo único
Cegamento (Mascaramento)
Nenhum (Aberto)
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalTelitacicept 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...Mostrar mais | Telitacicept The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks. |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
1-year relapse-free survival rate | The rate of no relapse within 1 year | 1-year period after enrollment |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
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 |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto
Idade mínima
2 Years
Sexos elegíveis
Todos
- 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 MedicineResponsável pelo estudo
Mao Jianhua, Investigador principal, Professor, The Children's Hospital of Zhejiang University School of Medicine
Contato central do estudo
Contato: Jianhua Mao, MD, 86057186670015, [email protected]
Contato: Chunyue Feng, [email protected]
1 Locais do estudo em 1 países
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, MD, Contato, 13616819071, [email protected]
Em recrutamento