2024-512491-35-00招募中2 期
Chronic kidney disease – imaging the metabolic derangements with ultra-sensitive MRI
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MRI signature of the kidney
研究概览
简要总结
In this study, we aim to assess the metabolic signature of CKD and PDK using multi-parametric MRI. The study will include healthy volunteers (N=8), CKD patients (N=12), PKD patients (N=10). PDK patients: a. The metabolic shift towards glycolysis compared with healthy kidneys can be detected using MRI with hyperpolarized pyruvate.
CKD patients a. Multi-parametric MRI combined with hyperpolarized pyruvate MRI can detect the metabolic alterations, including upregulated lactate and alanine production, associated with CKD. b. These alterations correlate with measures of fibrosis and inflammation from biopsies
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Aged 18 – 85 years (all participants)
- •Pre-menopausal women must be confirmed non-pregnant by an onsite test. (All female participants)
- •Autosomal dominant polycystic kidney disease. (PKD group)
- •CKD for any reason except PKD. (CKD group)
- •Recent biopsy (within 3 months of MRI). (CKD group)
- •eGFR > 60 (PKD patients)
排除标准
- •Contraindications for MRI with contrast: - eGFR less than 30 ml/min/1.73m2 - Significant cardiac disease such as severe left ventricular outflow obstruction - Significant obstructive lung disease or severe asthma - Pacemaker, neurostimulator or cholera implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Claustrophobia - Largest circumference including arms > 160 cm
- •Competing renal or systemic disease (except unspecific renal MRI findings, hypertension, atherosclerosis, well-regulated diabetes and hyperlipidemia/cholesterolemia which are allowed)
- •Renovascular disease
- •Allergy to pyruvate
结局指标
主要结局
MRI signature of the kidney
MRI signature of the kidney
次要结局
- Measures of kidney function in blood and urine.
- Expired CO2 measures
研究者
Malene Aastrup
Scientific
Aarhus Universitet
研究点 (1)
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