Low Energy Shockwave Therapy (LE-SWT): A Novel Treatment for Chronic Kidney Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Patient-reported quality of life
研究概览
简要总结
The investigators aim to investigate whether low energy shockwave therapy (LE-SWT) can preserve kidney function in diabetic patients. Participants in this study will receive LE-SWT treatment 6 times over 3 weeks. The treatment is non-invasive and has no known side effects. Previous studies have shown that LE-SWT induces angiogenesis. The investigators hypothesize that chromium-ethylenediaminetetraacetic acid (EDTA) renal clearance remains stable or increases in treated patients. Furthermore, kidney biopsy should show no signs of damage to the tissue and possibly neo-vascularization. In this project, the investigators shall also investigate LE-SWT effect on urinary markers of tubular damage and urinary nitric oxide indices. Patients' self-reported quality of life will be assessed using Short Form 36 version 2 (SF-36v2) Health Survey.
There is an 18-months follow-up on patients. Only patients between 18-65 years old with moderate chronic kidney failure from diabetes will be included.
This project is an interventional prospective study. 30 patients with moderate kidney failure will be recruited from the Department of Endocrinology, Odense University Hospital, Denmark. LE-SWT treatment will be performed in the ambulatory of Department of Urology. Patients will be hospitalized for 1 day in the Department of Nephrology when kidney biopsy is taken (two times in study period).
详细描述
1.0 Background
1.1 Definitions of chronic kidney disease
The Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF) defines chronic kidney disease as either kidney damage or a decreased glomerular filtration rate (GFR) of less than 60 mL/min/1.73m2 for 3 or more months.
Whatever the underlying etiology, the destruction of renal mass with irreversible sclerosis and loss of nephrons leads to a progressive decline in GFR. The different stages of chronic kidney disease form a continuum in time. In 2002, K/DOQI published its classification of the stages of chronic kidney disease (CKD), as follows:
Stage 1: Kidney damage with normal or increased GFR (>90 mL/min/1.73 m2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage 3: Moderate reduction in GFR in patients with diabetes mellitus (DM)
排除标准
- •CKD stage 1, 2, 4,
- •Blood pressure above 140/90 mmHg
- •Renography with less than 30 % differential function on one kidney
- •Kidney or ureteric stone
- •Obstructive uropathy
- •Kidney tumor
- •Chronic Urinary Tract Infection (UTI)
- •Single kidney
- •Bleeding disorders (coagulopathy)
- •Patient on anticoagulants
- •Coronary infarction during study period
- •LE-SWT for other reasons and non-diabetes mellitus kidney disease
- •Severe psychiatric disorder
- •Kidney transplant recipient
- •Pregnant or planning on becoming pregnant
结局指标
主要结局
Patient-reported quality of life
时间窗: 19 monts after enrollment (average time point).
SF-36v2 Health Survey scores
Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome)
时间窗: 19 months after enrollment (average time point).
Quantitative measurements of nitric oxide indices in urine
Histological assessment of fibrosis in kidney biopsy
时间窗: 19 months after enrollment (average time point).
Semi-quantitative determination of fibrotic tissue in kidney biopsy.
Albumin/creatinin ratio in spot urine sample
时间窗: 2 months after enrollment (average time point).
Assessment of glomerular damage in kidneys
Histological assessment of endothelial growth in kidneys
时间窗: 19 months after enrollment (average time point).
Semi-quantitative determination of endothelium in kidney biopsy.
Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample.
时间窗: 2 months after enrollment (average time point).
Assessment of tubular damage in kidneys
Chromium-EDTA clearance
时间窗: 19 months after enrollment (average time point).
Measurement compared to chromium-EDTA clearance prior to intervention
Changes in glomerulus basal lamina assessed using transmission electron microscopy.
时间窗: 19 months after enrollment (average time point).
Qualitative analysis of glomerulus basal lamina using transmission electron microscopy.
次要结局
- Patient-reported quality of life(10 months after enrollment (average time point).)
- Albumin/creatinin ratio in urine(2 months, 4 months, 7 months, and 19 months after enrollment (average time points).)
- Neutrophil Gelatinase-Associated Lipocalin (NGAL) concentration in spot urine sample.(Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).)
- Protein concentration in urine(2 months, 4 months, 7 months, and 19 months after enrollment (average time points).)
- Nitrite, nitrate and cGMP concentrations in spot urine sample (composite outcome).(Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points). Furthermore: 2 months, 4 months, 7 months, 10 months, 13 months, and 16 months after enrollment (average time points).)
- Albumin/creatinin ratio in spot urine sample(Day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).)
- Chromium-EDTA clearance(4 months and 7 months after enrollment (average time points).)
- 24 hour blood pressure monitoring(2 months, 4 months, 7 months, and 19 months after enrollment (average time points).)
- Haematoma in kidney(2 months, 7 months, and 13 months after enrollment (average time points).)
- Blood creatinine concentration (estimated glomerular filtration rate)(2 months, 4 months, 7 months, 10 months, 13 months, 16 months, and 19 months after enrollment (average time points).)
- Blood urea concentration(2 months, 4 months, 7 months, 10 months, 13 months, 16 months, and 19 months after enrollment (average time points).)
研究者
Sune Moeller Jeppesen
BSc.med
Odense University Hospital