Effect of Renin-angiotensin-system (RAS) Blocker Drugs on Chronic Kidney Disease (CKD) Progression in Elderly Patients With Non Proteinuric Nephropathies (PROERCAN01)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Chronic kidney disease progression
研究概览
简要总结
This study evaluates the effect of renin-angiotensin blockers on chronic kidney disease progression in elderly (>65 years old) patients with non-proteinuric nephropathies. Half of the patients will receive angiotensin converting enzyme inhibitors, while the other half will not receive them. Renal function, proteinuria and cardiovascular events will be follow up during a three year period.
详细描述
STUDY DESIGN: Open, multicentre, prospective, parallel-group, randomized controlled study comparing the effect of an angiotensin converting enzyme inhibitor (ACEI) vs standard antihypertensive treatment without ACEI, in the progression of renal disease in elderly patients with non-proteinuric 3-4 stage chronic renal disease.
Elderly patients (> 65 years) with moderate-severe non-proteinuric chronic renal disease (estimated Glomerular Filtrate Rate between 19-59 ml per minute per 1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration Group equation) and urine-creatinine rate < 30 mg/g, will be included. They will be randomly assigned in a 1:1 ratio to receive ACEI or standard antihypertensive treatment. Patients will be followed up for 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >65 years
- •Chronic kidney disease stage 3 or 4 (GFR measured by CKD-EPI 15-59 ml/min/1,73 m2)
- •Albumine/creatinine index < 30 mg/g in simple urine sample or albuminuria < 30 mg/day in 24-hour urine sample.
- •Previous hypertensive treatment::
- •patients who have not received RAS blockers in the three months prior to inclusion can be included
- •patients who are receiving RAS blockers could be included after one month washout period
排除标准
- •Diabetes mellitus (type 1 or 2)
- •Glomerulopathy
- •Chronic heart failure or coronary heart disease
- •Poorly controlled hypertension (>160/100 mmHg)
- •Monorrenal
- •Active malignant neoplasia (except skin cancer different from melanoma). Patients who have been free of malignancy for the last 5 years could be included.
- •Chronic symptomatic or not controlled inflammatory disease (eg rheumatoid arthritis, Chron disease, ulcerative colitis or systemic lupus erythematosus)
- •Chronic liver disease
- •Allergy or intolerance to renin angiotensin system blockers or calcium channel blockers
- •Hepatitis B, C or HIV infection
- •Immunosuppressive treatment in the 3 months prior to inclusion
- •Hospitalization of any cause in the three months prior to inclusion
- •Rapidly progressive kidney disease (decline in GFR >5ml/min/1.73 m2/year)
- •Inability to sign the informed consent
研究组 & 干预措施
RAS Blockers
Patients in this arm will receive Lisinopril 20mg/day
干预措施: Lisinopril (Drug)
Non RAS Blockers
Patients in this arm will receive Amlodipine 10mg/day or Lercanidipine 20mg/day +/- diuretics
干预措施: Amlodipine (Drug)
结局指标
主要结局
Chronic kidney disease progression
时间窗: 3 years
Increase of baseline creatinine during follow up period
次要结局
- Security of RAS blockers in elderly patients(3 years)
- Effects of RAS blockers on cardiovascular risk in elderly patients(3 years)
- Effect of RAS blockers on mortality in elderly patients(3 years)
研究者
Maria Maria Angeles Goicoechea Diezhandino
Nefrologist
Hospital General Universitario Gregorio Marañon