Prospektivt Randomiseret Dobbeltblindt Placebo-kontrolleret Studie af, Calciumkanalblokade påbegyndt Inden Operation: Med Henblik på at Forebygge Ciclosporin Induceret Nefropati Efter Lungetransplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in glomerular filtration rate
研究概览
简要总结
Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes. Calcium channel blockers may improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.
The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy.
The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo.
Study population is all patients listed for lung transplantation in Denmark in the study period.
Intervention is tablet felodipine titrated to 10 mg, one daily dose in 12 weeks
Primary endpoint is change in renal function as measured by glomerular filtration rate using chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) in the felodipine treated group compared with the placebo group.
详细描述
Lung transplanted patients experience marked decrease in renal function post transplant mainly due to cyclosporine induced renal changes.
Calcium channel blockers exert renal effects consisting mainly of renal vasodilation and facilitation of renal excretion of sodium through a direct action on renal tubules. Calcium channel blockers improve renal function in cyclosporine treated transplant recipients through their effects in avoiding cyclosporine-induced renal vasoconstriction and facilitating renal sodium output.
Studies in both animal models and humans have demonstrated that calcium channel blockers maintain or reduce renal vascular resistance and preserve or enhance renal blood flow and glomerular filtration rate (GFR).
The aim of this study is to examine if calcium channel blockade administered before lung transplantation prevent cyclosporine induced nephropathy.
The design is an intention to treat randomized double blinded single center study. Patients are randomized to two groups, one that received felodipine and one that receives placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •All patients who are undergoing lung transplantation in Denmark
排除标准
- •Fertile women not using contraceptives
- •Patients allergic to calcium antagonists
- •Patients receiving treatment with Calcium antagonist 14 days prior to transplant
研究组 & 干预措施
Felodipine
Tablet Felodipin 10 mg x 1 daily
干预措施: Felodipine (Drug)
Placebo
Identical placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Change in glomerular filtration rate
时间窗: week 1, 2, 3 and 12
glomerular filtration rate using chromium-51 labeled ethylenediamine tetraacetic acid (51-Cr-EDTA) at week 1, 2, 3 and 12
次要结局
未报告次要终点
研究者
Bo Feldt-Rasmussen
Professor
Rigshospitalet, Denmark