NCT06656962进行中（未招募）1 期
Renmin Hospital of Wuhan University
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The complete remission rate of AAGN
研究概览
简要总结
This study is a prospective, single-arm, open-label exploratory clinical study conducted in subjects with ANCA-associated nephritis (AAGN), aiming to evaluate the efficacy and safety of Telitacicept in the treatment of AAGN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years and ≤ 75 years, both male and female are included.
- •Clinically diagnosed as granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) according to the definition of the 2012 Chapel Hill Consensus Conference (CHCC).
- •Positive serological detection of autoantibodies, defined as follows: positive anti-proteinase 3 (PR3-ANCA) or anti-myeloperoxidase (MPO-ANCA) (previous or screening test results).
- •Renal involvement at screening, defined as at least one of the following: (1) At least one renal item in the Birmingham Vasculitis Activity Score (BVAS) version 3.0; (2) According to the pathological classification criteria formulated by the European Vasculitis Society (EUVAS) in 2003, there is active, biopsy-confirmed ANCA-associated nephritis (biopsy must be performed within 1 year before the screening visit or during the screening period); (3) Microscopic examination of urine shows red blood cell casts.
- •Voluntarily participate in this clinical trial and sign the informed consent form.
排除标准
- •Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.).
- •Secondary vasculitis (such as systemic lupus erythematosus, Henoch-Schönlein purpura, drugs, tumors, infections, primary immunodeficiency, etc.).
- •Patients with primary kidney diseases (such as IgA nephropathy, membranous nephropathy and anti-glomerular basement membrane nephritis, etc.).
- •Major or uncontrolled diseases unrelated to AAV.
- •Rapidly progressive glomerulonephritis with rapid decline in renal function: estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73m² before the first administration, or already receiving continuous dialysis treatment.
- •Patients with central nervous system diseases (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis).
- •Other multisystem autoimmune diseases including systemic lupus erythematosus, IgA, rheumatoid vasculitis, anti-glomerular basement membrane disease, cryoglobulinemic vasculitis, etc.
- •Active hepatitis or a history of severe liver disease or liver lesions (HBsAg positive, or HBcAb positive and HBV-DNA positive), active pulmonary tuberculosis.
- •Immunodeficiency, uncontrolled severe infection.
- •Abnormal laboratory indicators that need to exclude subjects include but are not limited to the following indicators: total bilirubin ≥ 3 times the upper limit of normal, alanine aminotransferase (ALT) ≥ 3 times the upper limit of normal, aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal, white blood cell (WBC) < 2.5×109/L, hemoglobin (Hb) < 85 g/L, platelet count (PLT) < 50×109/L.
- •Received any of the following treatments within 364 days before day 0: a) B-cell targeted therapy (e.g., rituximab, other anti-CD20 drugs, anti-CD22 [epratuzumab], anti-CD52 [alemtuzumab], BLyS receptor fusion protein [BR3], TACI-Fc); b) abatacept; c) experimental biological products.
- •Patients who have undergone kidney transplantation or other organ transplantation.
- •Received intravenous immunoglobulin or plasma exchange within 4 weeks before the first administration.
- •Pregnant women, lactating women and men or women with plans for childbearing during the trial.
- •Participated in other new drug clinical trials within 3 months before the first administration.
- •Psychiatric patients with depression or suicidal thoughts.
- •Have a history of major organ (such as heart, lung, kidney, liver) transplantation or hematopoietic stem cell/bone marrow transplantation or plan to receive transplantation.
- •Those with positive test results within 4 weeks before screening suggesting COVID-19 infection, or those with a severe history of COVID-19 requiring hospitalization within 12 months before screening.
- •Those allergic to Telitacicept.
- •Other diseases or conditions that the investigator deems inappropriate for participation in this trial.
研究组 & 干预措施
The Telitacicept treatment group
Experimental
干预措施: Telitacicept 160mg (Drug)
The Telitacicept treatment group
Experimental
干预措施: Prednisone (and methylprednisolone) (Drug)
The Telitacicept treatment group
Experimental
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
The complete remission rate of AAGN
时间窗: 24 weeks
The complete remission of AAGN is defined as no manifestations of glomerulonephritis (the renal item score of Birmingham vasculitis activity score \[BVAS\] is 0); the renal item score of BVAS can range from 0 to 58.
The partial remission rate of AAGN
时间窗: 24 weeks
The partial remission refers to no active urinary sediment, stable or decreased Scr level, or a reduction of more than 50% in the renal item score of Birmingham vasculitis activity score \[BVAS\]; the renal item score of BVAS can range from 0 to 58.
次要结局
- The complete remission rate of ANCA(24 weeks)
- The partial remission rate of ANCA(24 weeks)
- Safety and tolerability of patients, occurrence and recurrence of adverse events during the trial(24 weeks)
研究者
Huiming Wang
Director, Professor
Renmin Hospital of Wuhan University
研究点 (1)
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