DRKS00015866已完成不适用
MR-Progression-Evaluation of Chronic Kidney Disease - MR-P-CKD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 39 Years(—)
- 性别
- All
入选标准
- •healthy subjects: 18-39 years of age, Body Mass Index (BMI) between 17-30kg/m² and Cockcroft-Gault or MDRD estimate of creatinine clearance >70mL/min (based on medical reports not older than two years; otherwise blood will be drawn for a new evaluation).
- •ADPKD subjects: 18-39 years of age, diagnosis ADPKD (type I or II) based on a positive family history and/or at least three kidney cysts (unilateral or bilateral), BMI between 17-30kg/m², Cockcroft-Gault or MDRD estimate of creatinine clearance >70mL/min (based on medical reports not older than two years; otherwise blood will be drawn), no albuminuria, and total cystic volume under 350mL and 450mL for women and men, respectively. Participants with a disputable ADPKD diagnosis or unmeasured kidney and cysts dimensions will be able to undergo an MRI evaluation, in order to prevent subjects to undergo an unnecessary renal function scintigraphy test.
排除标准
- •healthy subjects: pregnancy, breast feeding, mean seated blood pressure above 145/95mmHg and seated heart rate above 100 beats per second, diabetes mellitus (fasting glucose >126mg/dl, treatment with insulin or oral hypoglycemics), known atrial fibrillation or atrioventricular block grade II or higher, history of myocardial infarction, unstable angina pectoris, evident congestive heart failure (New York Heart Association class III/IV), established renal impairment or chronic disease potentially affecting renal function, and intake of antihypertensive medication, nonsteroidal antiinflammatory drugs like acetylsalicylic acid or diuretics, implants, which are not safe for 3T.
- •ADPKD subjects: pregnancy, breast feeding, mean seated blood pressure above 160/100mmHg and seated heart rate above 100 beats per minute, diabetes mellitus (fasting glucose >126mg/dl, treatment with insulin or oral hypoglycemics), known atrial fibrillation or atrioventricular block grade II or higher, history of myocardial infarction, unstable angina pectoris, evident congestive heart failure (New York Heart Association class III/IV), established moderate renal impairment (GFR category G3a or higher and albuminuria category A2 or higher) or other systemic diseases potentially affecting renal function, intake of nonsteroidal antiinflammatory drugs like acetylsalicylic acid or diuretics, and previous renal surgery or cyst drainage procedures, implants, which are not safe for 3T..
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