NCT06564142进行中（未招募）3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Povetacicept in Adults With Immunoglobulin A Nephropathy (RAINIER)
Alpine Immune Sciences Inc, A Subsidiary of Vertex395 个研究点 分布在 1 个国家目标入组 605 人开始时间: 2024年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 605
- 试验地点
- 395
- 主要终点
- Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of povetacicept in adult participants compared with placebo in reducing proteinuria and preserving renal function.
详细描述
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Povetacicept in Adults with Immunoglobin A Nephropathy
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
- •Diagnosed IgAN, with biopsy confirmation
- •24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g
- •Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m^2
- •Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification
排除标准
- •Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol
- •Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening
- •Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Placebo Comparator
Participants will be randomized to receive placebo matched to Povetacicept.
干预措施: Placebo (matched to Povetacicept) (Drug)
Povetacicept
Experimental
Participants will be randomized to receive Povetacicept.
干预措施: Povetacicept (Drug)
结局指标
主要结局
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
时间窗: From Baseline at Week 36
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104
时间窗: From Baseline Through Week 104
次要结局
- Change From Baseline in eGFR at Week 104(From Baseline at Week 104)
- Time to Kidney Disease Progression Through Week 104(From Baseline Through Week 104)
- Change from Baseline in Serum Gd-IgA1 at Week 36(From Baseline at Week 36)
- Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)(From Baseline at Week 36)
- Change From Baseline in eGFR at Week 104(From Baseline at Week 104)
- Time to Kidney Disease Progression Through Week 104(From Baseline Through Week 104)
研究者
研究点 (395)
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