Saving Residual Renal Function Among Haemodialysis Patients Receiving Irbesartan - a Double Blind Randomised Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 6
- 主要终点
- Decrease in loss of residual kidney function.
研究概览
简要总结
Angiotensin II receptor blockers (ARB) are known to preserve kidney function among patients with kidney diseases and reduced renal function, but not among haemodialysis patients.
Haemodialysis patients often lose residual renal function after initiating dialysis leading to worsened quality of life, increased morbidity and mortality.
In this study an ARB is investigated in a double blind, randomised, parallel group, placebo controlled manner to see, if this ARB can save residual renal function among haemodialysis patients. Potential cardiovascular benefits of the treatment are also addressed.
详细描述
Haemodialysis patients often lose residual renal function rather quickly after initiation of dialysis - average loss is 30 % per year. Loss of residual kidney function leads to deteriorating quality of life, more morbidity and a higher mortality. Many causes to this has been identified, but no one has - to my knowledge - addressed saving of residual renal function among haemodialysis patients so far.
Hypothesis: Irbesartan can reduce loss of residual kidney function among haemodialysis patients and left ventricular hypertrophy and arterial stiffness is less pronounced after 1 year of treatment.
Methods: 80 patients are randomised to receive either irbesartan, an angiotensin II receptor blocker (ARB), or placebo for 1 year. Residual renal function will be estimated before and one-two weeks after initiating project medicine, in order to estimate the acute effect of ARB on residual renal function in this study population. Thereafter, glomerular filtration rate (GFR) and urine volume will be determined after 3, 6, 9 and 12 months giving a regression line for each patient. 8 dialysis units will be recruiting patients.
Investigations:
- creatinine-urea-clearance by 24h urine collection
- applanation tonometry
- cardiac output
- echocardiography
- QoL questionnaire
- endocrinological and cardiovascular markers in blood and urine
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Haemodialysis patient
- •Haemodialysis treatment for maximum 12 months
- •> 18 years old
- •informed consent
- •urine volume > 300 ml / 24 hours
- •contraception if fertile woman
排除标准
- •Systolic blood pressure < 110 mm Hg
- •Able to comprehend the aims of the project and follow instructions
- •Allergy to irbesartan/ACE-inhibitors/ARBs
- •Myocardial infarction or unstable angina pectoris during the last 3 months
- •Ejection fraction < 30 %
- •Pregnancy
研究组 & 干预措施
Irbesartan
干预措施: Irbesartan (Drug)
Placebo
干预措施: Placebo matching irbesartan 150 mg (Drug)
结局指标
主要结局
Decrease in loss of residual kidney function.
时间窗: 3, 6, 9 and 12 months
次要结局
- Cardio-vascular outcome assessed by applanation tonometry, echocardiography, Transonic measurements of cardiac output and markers in blood.(1 year)
- Progression to anuria(3, 6, 9 and 12 months)
- Quality of life assessed by a questionnaire: Kidney Disease Quality Of Life - Short Form (KDQOL-SF)(1 year)