Effect Camostat for Kidney Protection in Chronic Kidney Disease
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 24 h Urine sodium excretion (mmol/day)
研究概览
简要总结
This clinical trial aims to evaluate the effects of Camostat Mesylate, a serine protease inhibitor, in patients with chronic kidney disease (CKD) and proteinuria. Proteinuria accelerates CKD progression and increases cardiovascular risks. By inhibiting serine protease activity and tubular complement activation, camostat may mitigate progressive kidney injury, potentially improving clinical outcomes.
This is an interventional, non-randomized, open-label pharmacodynamic trial that includes CKD patients with proteinuria and healthy controls. This approach has been chosen as the trial serves as a pilot study, aiming to investigate a novel treatment target in CKD patients. Including healthy controls allows a comparison of the effect of Camostat Mesilate on normal physiology versus CKD with proteinuria.
Participants will:
- Follow a standardized sodium diet of 150 mmol/day for 8 days.
- Receive oral Camostat Mesilate (200 mg thrice daily) for four days (day 5-8 on the diet).
- Provide blood and urine samples, record blood pressure, and undergo body composition measurements at baseline, during intervention, and at study completion.
The primary effect parameters are urine sodium and water excretion, body water content/weight, and home blood pressure. Secondary endpoints are tubular complement activation, urine protease activity, ENaC activation, 24-hour urine albumin excretion, and plasma concentrations of renin, angiotensin II, aldosterone, and NT-proBNP.
详细描述
Please refer to the protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Chronic Kidney Disease patients
Patients with chronic kidney disease. eGFR > 30 ml/min/1,73 m^2 and U-ACR > 300 mg/g.
干预措施: Camostat Mesylate (Drug)
Healthy Controls
Healthy males and females in good general health and with no significant medical conditions or chronic illness.
干预措施: Camostat Mesylate (Drug)
结局指标
主要结局
24 h Urine sodium excretion (mmol/day)
时间窗: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Water excretion (L)
时间窗: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
24 h urine collection
Total Body Water (L)
时间窗: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
Measured by Body Composition Monistor
Home blood pressure
时间窗: At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).
次要结局
- Urine protease activity: zymography + protease activity(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)
- Tubular complement activation(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)
- Urine microvesicles: gammaENaC cleavage(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)
- 24 hours urine albumin excretion (mg/day)(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)
- Urine microvesicles: complement deposition(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)
- Plasma concentration of renin, NT-proBNP, angiotensin II and aldosterone(At baseline (day 0), before treatment with IMP (day 5), and after completion of 4 days treatment with IMP (day 9).)