JPRN-jRCT2080223899已完成2 期
A Phase II Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in IgA Nephropathy
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.Male or female of over 20 years of age
- •2.Renal biopsy report documenting IgAN
- •3.UPCR > 0.75 mg/mg by 24-hour urine collection during the Screening Period with at least one documented historical UPCR > 1 mg/mg within 12 months prior to the Screening visit while on 4.ACEi and/or ARB therapy, or UPCR > 1 mg/mg by 24-hour urine collection during the Screening Period
- •4.Initiation of ACEi and/or ARB at least 12 weeks prior to the Screening Visit. The dose of ACEi and/or ARB must be stable for at least 8 weeks prior to the Screening Visit
排除标准
- •1.Concomitant significant renal disease other than IgAN (eg, diabetic nephropathy, lupus nephritis, minimal change disease)
- •2.On kidney biopsy, more than 50percent glomeruli with global glomerulosclerosis, or more than 50percent of cortical area involved by tubular atrophy or interstitial fibrosis
- •3.Diagnosis of Henoch-Schonlein purpura
- •4.Renal or other organ transplantation prior to, or expected during, the study
研究者
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