The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria in Chronic Non-diabetic Kidney Disease: a Double-blind Cross-over Randomised Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
研究概览
简要总结
The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.
详细描述
Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.
The aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •age 18-65 years
- •chronic non-diabetic proteinuric nephropathy
- •chronic kidney disease stage 1-3
- •stable proteinuria above 500 mg/24 hours
- •blood pressure above 125/75 mmHg and below 150/95 mmHg
- •no steroids or other immunosuppressive treatment for a minimum of six months before the study
排除标准
- •unstable coronary heart disease
- •decompensated congestive heart failure in the previous 6 months
- •episode of malignant hypertension or stroke in the history
- •creatinine clearance below 30 ml/min
- •pregnancy
研究组 & 干预措施
C - A - B
(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
干预措施: aliskiren, eplerenon, telmisartan (Drug)
B - A - C
(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
干预措施: aliskiren, eplerenon, telmisartan (Drug)
A - B - C
(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg
干预措施: aliskiren, eplerenon, telmisartan (Drug)
结局指标
主要结局
Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms
时间窗: baseline and the end of 8 week treatments
changes of UACR
次要结局
- Difference in serum potassium and creatinine between treatment arms(baseline and the end of 8 week treatments)
- Difference in transforming growth factor beta (TGF-beta) between treatment arms(baseline and the end of 8 week treatments)
研究者
Leszek Tylicki
MD PhD
Medical University of Gdansk