NCT06740526招募中2 期
A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies in Adolescents and Adults With Immunoglobulin A Nephropathy
Otsuka Pharmaceutical Development & Commercialization, Inc.5 个研究点 分布在 2 个国家目标入组 25 人开始时间: 2024年11月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 5
- 主要终点
- Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
研究概览
简要总结
This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.
- •Source-verified kidney biopsy confirmed diagnosis of IgAN.
- •Participant has estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration [CKD EPI] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 [CKiD U25] eGFR equation for those younger than 18 years)
排除标准
- •Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.
- •Participant has coexisting chronic kidney disease, other than IgAN.
- •Participant has a serum IgG value <600 mg/dL at screening.
- •Participant is currently receiving or has received within 24 weeks prior to the firstdose of sibeprenlimab, systemic corticosteroids or immunosuppression (note:
- •topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids are allowed).
- •Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).
- •Participants who would be likely to require prohibited concomitant therapy during the trial.
研究组 & 干预措施
Sibeprenlimab
Experimental
干预措施: Sibeprenlimab (Drug)
结局指标
主要结局
Change from Baseline in Glomerular IgA Deposition by Immunofluorescence in Kidney Tissue to Week 52
时间窗: From Baseline to Week 52
次要结局
未报告次要终点
研究者
研究点 (5)
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