The Genetic Contribution to Drug Induced Renal Injury: The Drug Induced Renal Injury Consortium (DIRECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 634
- 试验地点
- 18
- 主要终点
- Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity.
研究概览
简要总结
Some medications are known to cause kidney damage because the person is allergic to the medication while others cause direct damage to the kidney because they are toxic at certain concentrations. Risk factors for developing kidney damage have been identified for some medications but not for all. Patients who are exposed to these important medications and develop problems with their kidneys may have some genetic risk. The purpose of this study is to determine the genetic risk factors for drug induced kidney injury. A better understanding of the role of genetics for the development of kidney injury from medications will allow us to better select medications, improve effectiveness of treatment and minimize harm.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 2 years and older
- •Exposure to a candidate drug for at least 24 hours (see above)
- •Patients who have developed DIRI as defined by the primary criteria
- •Written informed consent or assent and consent obtained
- •If patient lacks capacity to consent then surrogate consent will be obtained
排除标准
- •Patients with a history of or have a kidney transplant
- •Patients with a history of or have a bone marrow transplant
- •Patients with Chronic Kidney Disease stage 5 (eGFR < 15 mL/min/1.73m2)
- •Patients on 3 or more causal drugs
- •Patients with no history or time course on drug exposure
- •Patient who, in the opinion of the Investigator, is not suitable to participate in the study.
- •Unable to obtain written informed consent or assent
- •Unable to obtain surrogate consent for patients who lack capacity
结局指标
主要结局
Identify genes that predispose to dose dependent (Type A) or hypersensitivity (Type B) during drug induced nephrotoxicity.
时间窗: At time of enrollment
Blood Draw (20 cc) and urine collection (80cc)
次要结局
- To identify specific alterations in drug metabolism pathways that contribute to drug induced renal injury with different drugs.(DNA sample collected at time of enrollment.)
研究者
Ravindra Mehta
Professor of Clinical Medicine
University of California, San Diego