NCT03602807Unknown不适用
Safety and Effect of Low-Energy Extracorporeal Shockwave Therapy (ESWT) on the Renal Allograft in Transplant Recipients - a Pilot Study.
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in renal clearance (GFR)
研究概览
简要总结
The aim is to investigate the safety and potential effect of Low-energy Shockwave Therapy (ESWT) on the transplanted kidney. The treatment consist of ESWT two times a week for three weeks, six treatments in total.
The hypothesis is that ESWT with improve the renal function, by reducing proteinuria (in a 24-hour urine collection test) and improving renal clearance of 51Cr-EDTA.
The safety of ESWT on the renal allograft will be assessed during and after treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 1 year ago since last kidney transplant
- •P-Creatinin under 300, in the last 3 blood-samples
- •U-Albumine/creatinine ratio over 100, in the last 3 urine-samples
排除标准
- •Not Danish speaking.
- •Obstructive uropathy
- •Suspected autoimmune disease in the kidney graft
- •Symptomatic urinal tract infection (UTI)
- •Severe psychiatric disorder
- •Pregnant or planning on becoming pregnant
研究组 & 干预措施
Active treatment
Experimental
干预措施: Extracorporeal Shockwave Therapy (Device)
结局指标
主要结局
Change in renal clearance (GFR)
时间窗: At baseline and 3 months after treatment
Comparing GFR before and 3 months after treatment sessions
次要结局
- Change in albumin/creatine ratio in 24hour urine sample(At baseline, 1 month after treatment and 3 months after treatment)
- Incidens of treatment-related adverse events(up to 4 months)
研究者
Ronja Niemann Lundrup
Undergraduate researcher, BSc.med
Odense University Hospital
研究点 (2)
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