An Open-Label Phase 2 Study to Evaluate the Safety and Efficacy of CCX168 in Subjects With Immunoglobulin A Nephropathy on Stable RAAS Blockade
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 7
- 主要终点
- Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
研究概览
简要总结
The primary safety objective of this study is to evaluate the safety and tolerability of CCX168 in subjects with IgAN on background supportive therapy with a maximally tolerated dose of RAAS blockade. The primary efficacy objective is to evaluate the efficacy of CCX168 based on an improvement in proteinuria.
详细描述
Study acquired by Amgen and all disclosures were done by previous sponsor ChemoCentryx.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Immunoglobulin A nephropathy
- •estimated glomerular filtration rate >60 mL/min/1.73 m2
- •Proteinuria (first morning urinary protein:creatinine ratio >1g/g creatinine)
排除标准
- •Severe renal disease
- •Pregnant or nursing
- •Proteinuria >8g/g creatinine or >8g/day
- •Systemic manifestations of Henoch-Schonlein purpura within 2 years prior
- •Patients with Immunoglobulin A nephropathy deemed secondary to underlying disease
- •Biopsy reported severe crescentic Immunoglobulin A nephropathy
- •History of treatment with glucocorticoids, cyclophosphamide, azathioprine, mycophenolate mofetil, or any biologic immunomodulatory agent with 24 weeks prior
- •History of clinically significant cardiac conditions
- •History of cancer within 5 years prior
- •Any infection requiring antibiotic treatment that has not cleared prior to study start
研究组 & 干预措施
CCX168 (Avacopan)
CCX168 (Avacopan) plus stable dose of RAAS blocker
干预措施: CCX168 (Drug)
结局指标
主要结局
Change in Slope of First Morning Urinary PCR From the 8-week RAAS Blocker run-in Period to the 12-week CCX168 Treatment Period
时间窗: Week -8 to -1 (Run-in period) and Week 1 to 12 (treatment period)
The mean change in the slope of the urinary protein:creatinine ratio (UPCR, in mg/g/week) between the 8-week run-in period and the 12-week treatment period
Number of Participants With AE's
时间窗: Day 0 - Day 169 (throughout the trial)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Severity of Adverse Events (AE's)
时间窗: Day 0 - Day 169 (throughout the trial)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
次要结局
- Proportion of Subjects Achieving Renal Response From Baseline to Day 85(Baseline and Day 85)
- Proportion of Subjects Achieving a Partial Renal Response From Baseline to Day 85(Baseline and Day 85)
- Change in Systolic Blood Pressure From Baseline to Day 85(Baseline to day 85)
- Change From Baseline to Day 85 in Vital Signs(Baseline to day 85)
- Change in Diastolic Blood Pressure From Baseline to Day 85(Baseline to day 85)
- Change in Temperature From Baseline to Day 85(Baseline to day 85)
- Change in Weight From Baseline to Day 85(Baseline to day 85)