NCT05799287进行中（未招募）3 期
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Telitacicept in Patients With Primary IgA Nephropathy
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 318
- 试验地点
- 101
- 主要终点
- Change from baseline in urine protein creatinine ratio (UPCR)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).
详细描述
This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given subcutaneous injection（SC） Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B.
Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary informed consent provided;
- •Male or female aged ≥ 18 years old;
- •IgA nephropathy confirmed by pathological biopsy;
- •During the screening period, UPCR ≥ 0.8 g/g or 24-hour urine protein ≥ 1.0 g/day based on 24-hour urine collection at Visit 1 and/or Visit 2 and at Visit 3;
- •eGFR ≥ 30 mL/min per 1.73 m^2 (using the CKD-EPI);
- •Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.
排除标准
- •Subjects with abnormal laboratory tests, including but not limited to the following:
- •White blood cell count < 1.5×109/L
- •Neutrophils < 1.0×109/L
- •Hemoglobin < 85.0 g/L
- •Platelet count < 80.0×109/L
- •Total bilirubin >2×ULN
- •Alkaline phosphatase>2×ULN
- •Creatine kinase>5×ULN
- •IgA<10 mg/dL; or IgG≤400mg/dL；
- •Patients with secondary IgA nephropathy, including but not limited to: Henoch-Schonlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.;
- •Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;;
- •Renal transplant;
- •Patients with cirrhosis, as assessed by the investigator;
- •Patients who experienced any of the following cardiovascular and cerebrovascular events within 24 weeks prior to randomization: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA Class II or higher heart failure, stroke, etc.;
- •Sitting position SBP>140 mmHg or DBP>90 mmHg for at least once at 2 visits during the screening period;
- •Patients with poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c[HbA1c] > 8% or 64mmol/mol);
- •Treatment with immunosuppressants within 12 weeks prior to randomization, including but not limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii;
- •Treatment with anti-CD20 therapy (for example, Rituximb Injection) within 24 weeks prior to randomization;
- •Received systemic glucocorticoid treatment within 12 weeks prior to randomization, excluding the followings: ① received systemic treatment with prednisolone ≤ 0.5mg/kg or equivalent glucocorticoid for non- IgA nephropathy for no more than 3 courses (≤ 2 weeks per course) in the past 52 weeks; ② topical administration or nasal inhalation;
- •Had hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;
- •Patients with active tuberculosis;
- •Hepatitis B: patients with active or latent hepatitis B (potive HBcAb and HBV-DNA); According to the test results of hepatitis B five items, subjects with positive HBsAg will be excluded; subjects who are HBsAg-negative but HBcAb-positive, whether HBsAb is positive or negative, should be tested for HBV-DNA: if HBV-DNA is positive, patients should be excluded; if HBV-DNA is negative, patients can participate in the trial, and subjects are advised to take oral entecavir for prophylactic antiviral therapy during the trial;
- •Patients with hepatitis C;
- •Patients with HIV infection;
- •Patients with malignancy within the past 5 years, except for treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer in situ;
- •Pregnant women, lactating women, and subjects with childbearing plans during the trial;
- •Allergic to biological products of human origin;
- •Participated in any clinical trial within 4 weeks or within 5 times the half-life of the investigational drug participating (whichever is longer) prior to randomization;
- •Received live vaccination within 4 weeks prior to randomization;
- •Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
- •Other circumstances that, in the opinion of the investigator, are not suitable for participation in this study.
研究组 & 干预措施
Telitacicept
Experimental
Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
干预措施: Telitacicept (Biological)
Placebo
Placebo Comparator
Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in urine protein creatinine ratio (UPCR)
时间窗: 39 weeks
Based on a 24-hour urine collections.
Annualized estimated glomerular filtration rate (eGFR) slope
时间窗: 104 weeks
eGFR is calculated using the CKD-EPI formula.
次要结局
- Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline(39 weeks)
- Time to 30% reduction from baseline in eGFR(up to 104 weeks)
- Proportion of patients with a 40% decrease in estimated glomerular filtration rate (eGFR) compared with baseline(up to 104 weeks)
- Proportion of patients received rescue treatment.(up to 104 weeks)
- Incidence and severity of adverse events(up to 104 weeks)
- Change from baseline in urine protein creatinine ratio (UPCR)(52 weeks,78 weeks,104 weeks)
- Change from baseline in estimated glomerular filtration rate (eGFR)(39 weeks, 52 weeks,78 weeks,104 weeks)
- Change from baseline in UACR in urine albumin-to-creatinine ratio (UACR)(39 weeks, 52 weeks,78 weeks,104 weeks)
- Time to composite endpoint event(up to 104 weeks)
- Proportion of patients achieving urine protein creatinine ratio (UPCR) < 0.8 g/g(39 weeks, 52 weeks,78 weeks,104 weeks)
- Annualized estimated glomerular filtration rate (eGFR) slope(52 weeks)
研究者
研究点 (101)
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