NCT00140907已完成4 期
A Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Renal Protective Effects of Losartan in Patients With Renal Transplant
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 367
- 主要终点
- Incidence of chronic allograft nephropathy
研究概览
简要总结
To demonstrate that losartan (+ conventional therapy) compared to placebo (+ conventional therapy) will reduce the number of RT patients who experience histological lesions of chronic allograft nephropathy
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients With End Stage Chronic Renal Failure, Four To Eight Week After Receiving A First Or A Second Renal Transplant From A Dead Donor. In The Case Of A Second Transplant The Survival Of The First Graft Must Has Been 6 Month Or More
- •Patients Must Have A Serum Creatinine * 2 At Visit 1 And
- •Results Must Be Within 25% Of Each Other. The Baseline Period May Be Extended Until Four More Weeks To Obtain An Additional Serum Creatinine If One Of The First Two Serum Creatinine Results Do Not Qualify
- •Patients With Hypertension Must Have A Sitting Blood Pressure < 200/110 Mmhg At The Time Of Randomization
- •Normotensive Patients Must Have A Sitting Systolic Blood Pressure >100 Mmhg At The Time Of Randomization
排除标准
- •Hyperimmunized Patients At The Transplant Time Or In The Previous 6 Month, With A Pra of 50 %
- •Patients With Evidence Of Advanced Liver Disease
- •Serum Potassium <3.5 Or >5.5 Meq/L
- •History Of Allergy To Losartan
- •Other Factors Which May Affect Participation (E.G., Significant Concurrent Or Life Limiting Disease Such As Cancer In The Last Five Year Except Skin Neoplasias, Mental Or Legal Incapacitation, Drug Or Alcohol Abuse Within The Last 2 Years, Extensive Travel Planned In The Next 3 Years, Investigative Drug Trial Within The Last 4 Weeks)
- •Patients With Disseminated Or Localized Active Infectious Disease, At The Time Of Transplant
- •Acute Graft Rejection In The Grade III Of Banff Classification
- •Patients With Double-Transplant (Reno-Pancreatic)
- •Patients With Heart Failure Or History Of Myocardial Infarction Requiring Ace Inhibitor Or Aiia Therapies. Presence Or Known History Of Hemodynamically Significant Obstructive Valvular Disease Or Hypertrophic Cardiomyopathy
- •Renal Graft Artery Stenosis. An Eco-Doppler Test Must Be Performed In Order To Exclude A Graft Artery Stenosis
- •Pregnant Or Nursing Women
- •Chronic Use Of Nsaids
- •Major Psychotropic Agents Such As Phenothiazines Are Not Permitted, Use Of Lithium Is Not Permitted
研究组 & 干预措施
2
Active Comparator
Losartan
干预措施: losartan potassium (Drug)
结局指标
主要结局
Incidence of chronic allograft nephropathy
时间窗: 24 months post treatment
次要结局
未报告次要终点
研究者
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