Application of Functional Renal MRI to Improve Assessment of Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 486
- 试验地点
- 2
- 主要终点
- CKD progression
研究概览
简要总结
Research question: Can multiparametric renal Magnetic Resonance Imaging (MRI) provide structural and functional assessment of the kidneys to deliver prognostic information and guide treatment options in chronic kidney disease (CKD)?
Aims and objectives:
- To establish a multiparametric renal MRI protocol in CKD cohorts.
- To use multiparametric MRI to characterise people with and without CKD progression.
- To compare multiparametric renal MRI with 'gold-standard' renal biopsy to determine pathological processes of CKD progression that are detectable by MRI.
详细描述
The study will have three stages.
Stage 1: 45 people with CKD from nine UKRIN centres will undergo multiparametric MRI to test patient tolerance, data completeness and central data collection processes.
Stage 2: A multicentre, prospective cohort study of 450 people with CKD, collecting multiparametric renal MRI at baseline and 2 years. Long-term outcomes will be determined with efficient tracking of kidney failure events via the UK Renal Registry at 5 and 10 years.
Stage 3: A mechanistic sub-study of 45 patients (from Stage 2) who have had a routine renal biopsy. Detailed comparisons will be made between multiparametric MRI and histopathological changes. Tissue blocks will undergo quantitative analysis of fibrosis, capillary density and inflammation using immunohistochemistry techniques.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-75 years
- •CKD category G3-4 or CKD category G1-2 with overt albuminuria (urine ACR>30mg/mmol)
- •Capable of giving informed consent
排除标准
- •Autosomal dominant polycystic kidney disease (ADPKD)
- •Glomerulonephritis (GN) actively receiving immunosuppression, or within the preceding 90 days.
- •Multiple myeloma (MM)
- •Acute Kidney Injury (AKI) within the preceding 90 days
- •Solid organ transplant
- •Known single kidney
- •Contraindications to MRI (e.g. permanent pacemaker, metallic foreign bodies, claustrophobia etc.)
研究组 & 干预措施
Main study cohort
Patients with CKD recruited from specialist nephrology clinics
干预措施: Multiparametric renal MRI (Diagnostic Test)
结局指标
主要结局
CKD progression
时间窗: 10 years
kidney failure (doubling of serum creatinine, eGFR\<15ml/min or RRT) OR a 40% decline in eGFR
次要结局
- Kidney failure events(10 years)
- 40% decline in eGFR from baseline(10 years)
- AKI events(4 years)
- eGFR trajectory(2 years)
- Cardiovascular events(4 years)
- All cause mortality(10 years)