NCT03832114已完成2 期
An Open-label, Non-randomized Study on Efficacy, Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of LNP023 in Two Patient Populations With C3 Glomerulopathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)
研究概览
简要总结
The study is an open-label, two cohort non-randomized study evaluating the efficacy, safety, and pharmacokinetics of LNP023 in patients with C3G (Cohort A) and patients who have undergone kidney transplant and have C3G recurrence (Cohort B).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label study
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cohort A - no kidney transplant
Experimental
C3G patients who have not received a kidney transplant and have reduced C3 blood levels.
干预措施: LNP023 (Drug)
Cohort B - kidney transplant
Experimental
C3G patients who have received a kidney transplant and have C3G recurrence.
干预措施: LNP023 (Drug)
结局指标
主要结局
Cohort A: Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR)
时间窗: Week 12
Change in proteinuria assessed by ratio to baseline of UPCR derived from 24h urine collection
Cohort B: Change From Baseline in C3 Deposit
时间窗: Week 12
Histopathological changes in kidney biopsies as assessed by change from baseline in C3 Deposit Score (based on immunofluorescence microscopy)
次要结局
- Change From Baseline in Urine Albumin Creatinine Concentration Ratio (UACR) Excretion(Week 12: Day 84)
- Time to Reach the Maximum Plasma Concentration (Tmax)(Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose))
- Change From Baseline in Urine Protein Creatinine Concentration Ratio (UPCR)(Week 12: Day 84)
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR)(Day 84)
- Change From Baseline in Serum Creatinine(Week 12: Day 84)
- Number of Patients With Hematuria(Week 12: Day 84)
- Change From Baseline in Urine Protein to Creatinine Concentration Ratio (UPCR) First Morning Void(Week 9: Day 64)
- Change From Baseline in Urine Albumin to Creatinine Concentration Ratio (UACR) First Morning Void(Week 9: Day 64)
- Change From Baseline in Urine Protein (UP) Excretion(Week 12: Day 84)
- Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUClast (AUC)(Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose))
- Observed Maximum Concentration After Drug Administration (Cmax)(Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose))
- Change From Baseline Change in Urinary Albumin (UA) Excretion(Week 12: Day 84)
- Change From Baseline in Creatinine Clearance(Week 12: Day 84)
- Pharmacokinetics of LNP023 Area Under the Plasma-concentration-time Curve AUCtau (AUC)(Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose))
- Observed Minimum Concentration After Drug Administration (Ctrough)(Day 7, Day 14, Day 21, Day 28 (pre-dose, 0.5h, 1h, 2h, 4h, 6h, 8h post dose) and Day 36, Day 64 and Day 84 (pre-dose))
- Summary of Change From Baseline Complement C3 Biomarker in Serum(Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84)
- Ratio to Baseline Summary of Plasma Bb(Baseline, Day 1, Day 7, Day 14, Day 21, Day 28, Day 36, Day 64, Day 84)
研究者
研究点 (1)
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