NCT01091324Unknown3 期
The Reno-protective and Cardiovascular Effect of Dextromethorphan and Silymarin in Patients With Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change of eGFR
研究概览
简要总结
The investigators test the renal and cardiovascular protective effects dextromethorphan and silymarin on patients with the proteinuric chronic kidney diseases, who enrolled in our clinical trial, had progressing kidney diseases and merit aggressive anti-inflammatory therapy.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Stage 3 or 4 chronic kidney disease as measured by a Modification in Diet in Renal Disease Study (MDRD) estimate of between 15 ml/min and 59 ml/min and and 0.5 g/day<proteinuria<3g/day.
- •Age between 18 and 75 years old.
- •Patients without hospitalization for cardiac or infection related morbidity over the previous 2 months(due to the potential confounding effects on baseline study variables).
- •Patients who are able to provide consent to participate in the study.-
排除标准
- •patients will significant mental illness, pregnant women, and other vulnerable populations.
- •Patients with active hepatic disease and/or ALT > 2.5 times upper limit of normal.
- •Patients with history of congestive heart failure and NYHA Class III-IV symptoms at any time.
- •Patients for whom living donor renal transplantation is already scheduled or in the process of being evaluated, as these patients will be unlikely to complete study protocols before transplantation.
- •Patients with severe co-morbid conditions (eg, symptomatic hepatic cirrhosis, metastatic cancer, HIV infection with AIDS).
- •Patient with active inflammatory process (eg., SLE, rheumatoid arthritis, gout) for which they are currently receiving immune modulating medications.
- •Patients who are on corticosteroid therapy.
- •Patients who do not consent to participate in the study.
研究组 & 干预措施
Dextromethorphan
Active Comparator
干预措施: Dextromethorphan (Drug)
sugar pill
Placebo Comparator
干预措施: sugar pill (Drug)
Silymarin
Active Comparator
干预措施: Silymarin (Drug)
结局指标
主要结局
change of eGFR
时间窗: 4 months
Use MDRD-simplified equation
Change of Urine TP/Cr
时间窗: 4 months
Change of serum hsCRP
时间窗: 4 months
Change of urine TGF-beta/Cr level
时间窗: 4 months
fibrotic marker of kidney
Endothelial function
时间窗: 4 months
by Flow-mediated dilatation mesured by Crdiovascular ultrasound
次要结局
- Leukocyte ROCK activity(4 months)
- Blood MDA level(4 months)
- Blood TGF-beta(4 months)
- Urine MCP-1/Cr level(4 months)
研究者
研究点 (1)
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