A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Safety and Efficacy of ANG-3070 in Patients With Primary Glomerular Disease and Persistent Proteinuria
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 27
- 主要终点
- Percentage change in 24-hour urinary protein excretion at Week 12
研究概览
简要总结
The major objective is to demonstrate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria.
详细描述
To evaluate the safety and efficacy of ANG-3070 in patients with primary glomerular disease and persistent proteinuria while on the SOC, as measured by a reduction in the 24-hour urinary protein excretion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male or female participants aged 18 and older.
- •Diagnosis of a primary glomerular disease confirmed from a past renal biopsy. Participants with genetic forms of FSGS may be enrolled without a renal biopsy if the clinical picture is consistent with the genetic testing results.
- •Estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) ≥ 40 mL/min/1.73m
- •Urinary protein excretion ≥ 1 g/day on a 24-hour urine collection.
- •All participants must be on the SOC therapy, including the maximally tolerated/recommended doses of an ACEi or ARB, but not both.
排除标准
- •Positive Hepatitis B (HBV), Hepatitis C (HCV), or human immunodeficiency virus (HIV) viral screening; historical or during screening.
- •Aspartate Aminotransferase (AST) or alanine Aminotransferase (ALT) or total bilirubin > 2 x ULN.
- •Hemoglobin A1C > 8.5%.
- •Known predisposition to bleeding and/or thrombosis
- •Type I diabetes mellitus.
- •Renal disease secondary to systemic disease including but not limited to: systemic lupus erythematosus, anti-neutrophil cytoplasmic antibodies -associated diseases, anti-glomerular basement disease, secondary forms of focal segmental glomerulosclerosis, renal diseases associated with para-proteinemias, C3 glomerulopathy, and diabetic kidney disease.
研究组 & 干预措施
200 mg QD
200 mg of ANG-3070 will be taken once daily for 12 weeks.
干预措施: ANG-3070 (Drug)
400 mg QD
400 mg of ANG-3070 will be taken once daily for 12 weeks
干预措施: ANG-3070 (Drug)
300 mg BID
300 mg of ANG-3070 will be taken twice a day for 12 weeks.
干预措施: ANG-3070 (Drug)
Placebo
Placebo capsules will be taken once or twice daily for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in 24-hour urinary protein excretion at Week 12
时间窗: Week 12
次要结局
未报告次要终点