NOX4, Mitochondria and Related Biomarkers in Autosomal Dominant Polycystic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- NOX4 levels
研究概览
简要总结
To determine the value of NOX4, markers of mitochondria injury and function, and oxidative stress as real-time biomarkers to assess disease severity in patients with early autosomal dominant polycystic kidney disease (ADPKD).
详细描述
This will be a cross sectional study and will include male and female, young (15-40-years) well characterized patients with early (eGFR>70mL/min/1.73m2) ADPKD. Patients with different classes of disease severity will be selected using the ADPKD imaging classification. The study will include 60 class-1 (A-E) patients (N=12 per each sub-class).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 15 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ADPKD (based on Ravine et al. criteria)
- •Class 1 A-E according to imaging classification
- •Male and female subjects 15 - 40 years of age
- •Estimated GFR> 70 mL/min/1.73 m2 (CKD-EPI)
- •Ability to provide written, informed consent
排除标准
- •Class 2 according to imaging classification
- •Concomitant systemic disease affecting the kidney
- •Diabetes mellitus
- •Predicted urine protein excretion in >1 g/24 hrs
- •Use of antioxidants i.e. vitamins, Nrf2 activators
- •Abnormal urinalysis
研究组 & 干预措施
Patients with a previous diagnosis of ADPKD
Patients that have been diagnosed with ADPKD and are classified as Class 1A, 1B, 1C, 1D and 1E.
结局指标
主要结局
NOX4 levels
时间窗: Baseline
Determination of NOX4 levels from urine and plasma samples
mtDNA copy number
时间窗: Baseline
Determination of mtDNA copy number from urine and plasma samples
Tricarboxylic Acid (TCA) cycle metabolites
时间窗: Baseline
Determination of TCA cycle metabolite concentration from urine and plasma samples
REDOX status
时间窗: Baseline
Determination of REDOX from urine and plasma samples
Total kidney volume (TKV)
时间窗: Baseline
Determined by MRI
次要结局
- Estimated Glomerular Filtration Rate (eGFR)(Baseline)
研究者
Maria V. Irazabal Mira
Principal Investigator
Mayo Clinic