NCT07604311招募中4 期
Efficacy and Safety of Nefecon on Prevention of Relapse of IgA Nephropathy: a Randomized, Double-blinded, Placebo-Controlled Trial
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Time to first composite disease relapse
研究概览
简要总结
IgA nephropathy (IgAN) is a chronic progressive kidney disease, and long-term control of proteinuria and prevention of relapse are crucial for delaying disease progression. Patients with IgAN who achieve proteinuria remission after receiving Nefecon for 9 months or longer still face the risk of proteinuria relapse after treatment discontinuation. This study is to evaluate the efficacy and safety of Nefecon 8 mg treatment for 15 months as a maintenance therapy to reduce the risk of IgAN relapse in proteinuria-remitted patients.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed primary IgAN with biopsy verification;
- •Female or male participants ≥18 years of age;
- •Completion of ≥9 months of Nefecon 16 mg QD at the baseline visit;
- •Proteinuria ≥ 1g/d prior to initiation of Nefecon;
- •Proteinuria<0.5 g/day (or UPCR <0.5 g/g) at screening and randomization visit;
- •eGFR ≥30 ml/min/1.73m² at screening;
- •On stable treatment with supportive treatment (including RAASi, SGLT2i, ERA) for at least 1 month prior to the baseline visit;
排除标准
- •Systemic diseases that may cause mesangial immunoglobulin A deposition, including but not limited to IgA vasculitis nephritis, systemic lupus erythematosus, dermatitis herpetiformis, ankylosing spondylitis, and others;
- •Type 1 or type 2 diabetes mellitus;
- •Presence of primary or secondary glomerulopathies (e.g., membranous nephropathy, focal segmental glomerulosclerosis, C3 glomerulopathy and others);
- •Active infection, severe hepatic impairment (Child-Pugh Class C), congestive heart failure, and malignant tumor within the past 5 years;
- •On current or planned dialysis or kidney transplantation;
- •Participants who have been treated with systemic glucocorticoids and immunosuppressive agents within the past 3 months, including mycophenolate mofetil, hydroxychloroquine, cyclophosphamide, azathioprine, leflunomide, calcineurin inhibitors, and Chinese traditional medicines with immunosuppressive effects (such as Tripterygium wilfordii, Sinomenium acutum, Tripterygium Glycosides Tablets, Kunxian Capsules, Kunming Shanhaitang Tablets, etc.); treatment with B-cell targeted biological agents (such as telitacicept and sibeprenlimab, etc.); complement pathway inhibitors, etc.;
- •Poorly controlled hypertension (resting systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg);
- •Participants taking potent inhibitors of cytochrome P450 (CYP) 3A4 within the past 1 month, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or cyclosporine;
- •Females who are pregnant, breastfeeding, or planning to become pregnant in the trial period.
- •Any other conditions that, in the investigator's judgment, make the patient ineligible for this clinical study.
研究组 & 干预措施
Control
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Treatment arm
Experimental
NEFECON
干预措施: NEFECON (Drug)
结局指标
主要结局
Time to first composite disease relapse
时间窗: 15 months
either a ≥100% increase in UPCR and an absolute UPCR ≥0.5 g/g, or a ≥30% decline in eGFR from randomization
次要结局
- The proportion of patients with UPCR ≥0.5 g/g(15 months)
- The proportion of patients with UPCR ≥1 g/g(15 months)
- All-cause mortality(15 months)
研究者
研究点 (1)
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