A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Praliciguat in Patients With Biopsy-Confirmed Focal Segmental Glomerulosclerosis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 25
- 主要终点
- Change from Baseline in urine protein-to-creatinine ratio (UPCR)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of praliciguat in adults with biopsy-confirmed focal segmental glomerulosclerosis (FSGS). Participants will be randomized 1:1 to receive praliciguat or placebo for initial 24 week treatment period. Following this double-blind period, all participants will receive praliciguat in an open-label extension for an additional 24 weeks.
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
- •UPCR ≥1 (g/g) during screening.
- •On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent.
- •Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •Kidney biopsy collected within 5 years of screening consistent with FSGS or kidney biopsy collected ≥5 years prior to screening consistent with FSGS plus the presence of a pathogenic gene mutation known to be associated with FSGS.
排除标准
- •Collapsing FSGS in the kidney biopsy report.
- •Sickle cell disease.
- •HbA1c >8%.
- •Uncontrolled hypertension (≥160/100 millimeters of mercury).
研究组 & 干预措施
Placebo
Matching placebo will be administered daily for 24 weeks
干预措施: Placebo (Other)
Praliciguat
Praliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.
干预措施: Praliciguat (Drug)
结局指标
主要结局
Change from Baseline in urine protein-to-creatinine ratio (UPCR)
时间窗: Baseline (Day 1) and up to Week 24
次要结局
- Plasma concentrations of praliciguat(Week 24, Week 32, and Week 36)
- Percentage of Participants with Partial Remission at Week 24(Up to Week 24)