A Trial of Doxycycline in Renal Disease (ADORE)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Serum markers of fibrosis
研究概览
简要总结
The goal of this trial is to evaluate whether subantimicrobial-dose of doxycycline (20mgBID) will affect serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease.
详细描述
This is a Phase I, placebo-controlled, randomized crossover trial to determine the effects of 4-week treatment with subantimicrobial-dose doxycycline on serum and urine biomarkers of fibrosis in patients with pre-dialysis chronic kidney disease (eGFR<30ml/min/1.73m2). Doxycycline is a matrix metalloproteinase inhibitor and is approved for use as an anti-fibrotic in the setting of gum and skin disease at low doses (20mgBID). At such a dose, serum levels are too low for antimicrobial effect and chronic usage is not thought to lead to tetracycline resistance. Investigators hypothesize that doxycycline will ameliorate cardiac and renal fibrosis and thus investigators will detect a decrease in fibrotic markers during treatment with doxycycline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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
- •CKD pre-dialysis (eGFR< 30 ml/min/1.73m2 not on dialysis);
- •local 415/650/510 area codes;
- •primary language English or Spanish
排除标准
- •eGFR worsening by greater than 5ml/min/1.73 m2 during the last 6 months;
- •Systolic blood pressure less than 100mmHg or greater than 170 mmHg;
- •pregnancy;
- •ejection fraction less than 45%;
- •NYHA class III or IV HF;
- •myocardial infarction or hospitalization for HF within 4 months;
- •liver disease;
- •moderate or severe chronic obstructive pulmonary disease or pulmonary fibrosis;
- •current infection;
- •chemotherapy;
- •major surgery within last month;
- •bilateral dialysis access precluding lab draw;
- •self-reported use of IV drugs or cocaine within the last 6 months.
研究组 & 干预措施
Placebo-Doxycycline
Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days.
干预措施: Doxycycline (Drug)
Doxycycline-Placebo
Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days.
干预措施: Doxycycline (Drug)
Doxycycline-Placebo
Doxycycline 20mg capsule for 30 days, 30-day washout, and then placebo capsule for 30 days.
干预措施: Placebo (for Doxycycline) (Drug)
Placebo-Doxycycline
Placebo capsule for 30 days, 30-day washout, and then Doxycycline 20mg capsule for 30 days.
干预措施: Placebo (for Doxycycline) (Drug)
结局指标
主要结局
Serum markers of fibrosis
时间窗: 3 months
Serum collagen type III amino-terminal propeptide (PIIINP), soluble suppression of tumorigenicity 2 (ST2)
Urinary markers of fibrosis
时间窗: 3 months
Urinary PIIINP, Urinary alpha-1 macroglobulin (A1M)
次要结局
- Adverse effects(3 months)