An Open-label Extention (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients with IgA Nephropathy Who Have Completed Study Nef-301 in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Change in urine protein to creatinine ratio (UPCR) after 9 months
研究概览
简要总结
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients who have completed Nef-301 and continue to be treated with a stable dose of Renin-angiotensin system (RAS) inhibitor therapy (Angiotensin-converting enzyme inhibitors (ACEIs) and/or Angiotensin II type I receptor blockers (ARBs).
详细描述
This is a Phase 3b, multicenter, open-label extension (OLE) study to evaluate the efficacy and safety of Nefecon treatment in Chinese patients with Immunoglobulin A nephropathy (IgAN) who have completed Nef 301 study and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs).
During Study open-label extension (OLE) study, patients will receive Nefecon for a 9-month period. The patient will come for a follow-up visit at 12 months after first dose.
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
盲法说明
This is an open label, single-arm study with active treatment.
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
- •Patients that completed study Nef-
- •On a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) at the maximum allowed dose or maximum tolerated dose according to the 2012 Kidney Disease: Improving Global Outcomes (KDIGO) guidelines.
- •Willing and able to provide written informed consent.
- •Urine protein to creatinine ratio (UPCR) equal to or more than 0.5 g/gram or Average proteinuria equal or more than 0.75 g/day.
- •eGFR equal to or more than 30 mL/min per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
排除标准
- •Systemic diseases that may cause mesangial Immunoglobulin A (IgA) deposition.
- •Patients who have undergone a kidney transplant.
- •Patients with presence of other glomerulopathies and/or nephrotic syndrome.
- •Patients with acute, chronic, or latent infectious disease including hepatitis, tuberculosis (TB), human immunodeficiency virus (HIV), and chronic urinary tract infections.
- •Patients with liver cirrhosis, as assessed by the Investigator.
- •Patients with a diagnosis of type 1 or type 2 diabetes mellitus which is poorly controlled.
- •Patients with history of unstable angina, class III or IV congestive heart failure, and/or clinically significant arrhythmia, as judged by the Investigator.
- •Patients with unacceptable blood pressure control defined as a blood pressure consistently above national guidelines for proteinuric renal disease, as assessed by the Investigator.
- •Patients with diagnosed malignancy within the past 5 years.
研究组 & 干预措施
Nefecon active treatment
Nefecon 16mg once daily for 9 months.
干预措施: Nefecon (Drug)
结局指标
主要结局
Change in urine protein to creatinine ratio (UPCR) after 9 months
时间窗: 9 months
The outcome is measured as urine protein to creatinine ratio (UPCR) based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline.following the first dose of Nefecon compared to baseline.
The incidence of treatment emergent adverse events
时间窗: from enrollment up to 12 months
Adverse event data collection
Change in estimated glomerular filtration rate(eGFR) at 9 months
时间窗: 9 months
The outcome is measured as change in eGFR at 9 months following the first dose of Nefecon compared to baseline.
次要结局
未报告次要终点