The Autosomal Dominant Polycystic Kidney Disease (ADPKD) Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Change in GFR as compared to change in renal volume over time
研究概览
简要总结
The purpose of this study is to find out if radiology tests of the kidneys as opposed to glomerular filtration (GFR) tests (GFR test - a lab test that measures kidney function) follow progression of polycystic kidney disease (PKD) the best. PKD patients at risk for progression to renal failure (dialysis or transplantation) have been identified and include those who have been diagnosed with high blood pressure early, the presence of the PKD1 gene (the inherited abnormality responsible for the majority of PKD), men as opposed to women, those with episodes of visible blood or increased protein in their urine, and women who have experience more than three pregnancies. Individuals who are diagnosed with PKD in the first year of life or in utero (before birth) are also at high risk for progression to renal failure.
This study will also facilitate understanding of human diseases at the cellular and molecular level. We will be identifying genetic factors that may influence the severity of polycystic kidney disease (PKD). You are being asked to provide a sample of blood for the purpose of DNA or other biochemical analyses.
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
- — 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hypertension diagnosed early in the course of the disease (less than 25 years for men; less than 30 years for women)
- •ADPKD diagnosed in utero or in the first year of life
- •The presence of proteinuria (between 180 mg and 1 gm/day) without evidence of a second renal disorder
- •A history of more than 3 pregnancies and hypertension
- •A history of gross hematuria
- •A serum creatinine concentration less than 1.4 mg/dl
- •ADPKD diagnosed in childhood with more than 10 cysts
- •Serum creatinine concentration >1.4 and
- •Renal length greater than 15 cm and
- •Age less than 60 years of age
- •Severe pain or discomfort as assessed by the primary care physician related to ADPKD
排除标准
- •Subjects, who in the assessment of the principal investigator cannot provide reliable follow-up
- •Subjects who cannot be exposed to iothalamate
- •Subjects who cannot undergo MRI due to the presence of a pacemaker or surgical clip in the abdomen
- •Subjects who are not anticipated to survive during the duration of the study (e.g. underlying malignancy)
- •Subjects who cannot provide informed consent
- •Women who are pregnant or who have undergone a pregnancy in the last 6 months or who are presently breastfeeding
结局指标
主要结局
Change in GFR as compared to change in renal volume over time
时间窗: Three years
次要结局
- Differences in the ability to determine change in renal volume over time between MRI and ultrasound(Three years)
研究者
Arlene Chapman
Principal Investigator
Emory University