Feasibility Study of Metformin Therapy in Autosomal Dominant Polycystic Kidney Disease.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Safety and Tolerability of Metformin
研究概览
简要总结
This study is being done to determine if treatment with metformin, a drug widely used for the treatment of diabetes type 2, is safe and well tolerated by individuals with Autosomal Dominant Polycystic Kidney Disease (ADPKD) who are not diabetic and who have slightly decreased kidney function. The study will also evaluate the effects of metformin on kidney growth and kidney function.
详细描述
Patients with ADPKD are still in need for a well-tolerated treatment that can be used long-term to prevent cyst growth and kidney function decline. Metformin has a long track record of a low risk-to-benefit profile in patients with diabetes or at risk for diabetes. Metformin inhibits two key processes responsible for the growth of polycystic kidneys, i.e. fluid secretion and cell proliferation, as shown in cell cultures and animal models of ADPKD. Experiments in animal models of chronic kidney disease demonstrate that metformin administration prevents kidney fibrosis and preserves kidney function. Diabetic patients who are treated with metformin appear to develop less kidney failure and live longer than patients who are treated with other anti-diabetic medications. Therefore this drug is promising for people with ADPKD, with the potential to slow cyst enlargement and preserve kidney function.
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
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Autosomal Dominant Polycystic Kidney Disease and
- •An estimated glomerular filtration (GFR) rate of 50-80 ml/min/1.73 m2;
- •Subject is able to sign an Informed Consent
排除标准
- •Diabetes mellitus,
- •Active infection,
- •Congestive heart failure,
- •Liver disease,
- •Alcohol or substance dependence,
- •Cigarette smoking within the last 12 months;
- •Females who are pregnant or breast feeding, or
- •Are unwilling to use contraception;
- •Are unable to undergo magnetic resonance imaging, or
- •Have a contraindication to the use of metformin
研究组 & 干预措施
Metformin
Participants will receive metformin 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.
干预措施: Metformin (Drug)
Placebo
Participants will receive placebo 500 mg tablets, starting with 1 tab twice a day. The dose will be increased by 500 mg every 2 weeks up to 1000 mg by mouth twice a day, as tolerated, for 12 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and Tolerability of Metformin
时间窗: 12 months
Percentage of participants who at the end of 12 months are still prescribed the full randomized dose of metformin or placebo, and the percentage of participants who are prescribed at least 50% of the randomized dose
次要结局
- Change in Total Kidney Volume(12 months)
- Change in Kidney Function(12 months)
- Rate of Serious Adverse Events (SAE)(12 months)