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임상시험 NCT06125405 (STERN)은(는) 소아 신증후군, 텔리타시셉트에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
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카드 뷰
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome (STERN) 3상 20 소아
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT06125405 (STERN)은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 소아 신증후군, 텔리타시셉트에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2023년 11월 28일에 시작되어 20명의 참여자를 모집하고 있습니다. The Children's Hospital of Zhejiang University School of Medicine이(가) 진행하며, 2027년 10월 24일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2024년 8월 21일에 갱신되었습니다.
간단한 개요
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.
상세한 설명
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...더 보기
공식 제목
Study of the Telitacicept in Pediatric Patients With Frequently Relapsing or Steroid Dependent Nephrotic Syndrome
질환명
소아 신증후군텔리타시셉트출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- STERN
NCT 번호
실제 연구 시작일
2023-11-28
최신 업데이트 게시
2024-08-21
예상 연구 완료일
2027-10-24
계획된 등록 인원
20
연구종류
중재연구
단계/상
3상
상태
모집중
키워드
Telitacicept
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
Frequently Relapsing Nephrotic Syndrome
Steroid Dependent Nephrotic Syndrome
주요 목적
치료
설계 할당
해당 없음
중재 모델
단일군설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Telitacicept 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...더 보기 | Telitacicept The study duration was 52 weeks, with the experimental group receiving subcutaneous injections of Telitacicept once weekly for a total of 52 weeks. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
1-year relapse-free survival rate | The rate of no relapse within 1 year | 1-year period after enrollment |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
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 |
참여 도우미
적격성 기준
연령대
어린이, 성인
최소 연령
2 Years
참여 가능한 성별
전체
- 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 Medicine연구 책임자
Mao Jianhua, 책임연구자, Professor, The Children's Hospital of Zhejiang University School of Medicine
연구 대표 연락처
연락처: Jianhua Mao, MD, 86057186670015, [email protected]
연락처: Chunyue Feng, [email protected]
1 1개국에 임상시험 장소
Zhejiang
Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Jianhua Mao, MD, 연락처, 13616819071, [email protected]
모집중