An Open-Label Extension (OLE) Study to Evaluate the Efficacy and Safety of Nefecon Treatment in Patients With IgA Nephropathy Who Have Completed Study Nef-301
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 7
- 主要终点
- Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline
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 patients with IgAN who have completed the Phase 3 Study Nef-301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon.
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 patients with IgAN who have completed the Phase 3 Study Nef 301 and continue to be treated with a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs). Patients who previously received Nefecon in Study Nef-301 will receive retreatment, whereas patients who previously received placebo in Study Nef-301 will be treatment naïve to Nefecon. During Study Nef-301 OLE, the patients and Investigators will remain blinded to treatment given in Study Nef-301.
During Study Nef-301 OLE, patients will receive Nefecon for a 9-month period. The dose may be reduced if clinically relevant adverse events (AEs) develop during the 9-month Treatment Period that the Investigator considers related to the study drug and that mandate dose reduction.
Patients will remain on a stable dose of RAS inhibitor therapy (ACEIs and/or ARBs) throughout the study. 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
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-301
- •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 KDIGO guidelines
- •Willing and able to provide written informed consent.
- •UPCR equal to or more than 0.8 g/gram
- •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 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
Active Nefecon treatment
Nefecon 16 mg once daily by mouth for 9 months
干预措施: Nefecon 16mg daily (Drug)
结局指标
主要结局
Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline
时间窗: 9 months
The outcome is measured as UPCR based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram
Ratio of Estimated Glomerular Filtration Rate (eGFR) at 9 Months Compared to Baseline
时间窗: 9 months
The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 9 months following the first dose of Nefecon compared to baseline. I.e. eGFR at 9 months divided by eGFR at Baseline.
次要结局
- Number of Patients Receiving Rescue Treatment(12 months)
- Proportion of Patients on Dialysis, Undergoing Kidney Transplantation, or With eGFR <15 mL/Min Per 1.73 m2(12 months)
- Change From Baseline Cortisol Suppression at 9 Months(Baseline & 9 months)
- Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months Compared to Baseline(9 months)
- Change From Baseline Cortisol Suppression at 12 Months(Baseline & 12 months)
- Change From Baseline Short Form 36 (SF-36) Quality of Life Assessment at 12 Months(Baseline & 12 months)
- Number of Patients With Microhematuria at 9 Months Compared to Baseline(9 months)