NCT00461136已完成1 期
An Open-label, One-period, One-treatment Study to Evaluate the Time Course of the Antiproteinuric and Blood Pressure Lowering Effects After Initiation of Renin Inhibition With Aliskiren in Type 2 Diabetes Suffering From Incipient and/or Established Nephropathy
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
研究概览
简要总结
This study will evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria).
- •Incipient and established diabetic nephropathy (urinary albumin excretion ≥ 100 mg/day but ≤ 2000 mg/day).
- •Glomerular filtration rate (GFR) ≥ 40 ml/min (estimated using Modification of Diet in Renal Disease (MDRD) formula) in the last 4 months.
- •Female patients must be postmenopausal or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening.
- •To be eligible patients must fulfill the following criteria: Patients on ongoing hypertensive therapy must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1) AND patients must be on stable antihypertensive medications for at least 8 weeks prior to baseline (Day -1).; Newly diagnosed hypertensive patients must have a blood pressure ≥ 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1).
- •Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 ( Day -1).
- •Patients must be willing and medically able to discontinue all Angiotensin-converting enzyme inhibitor (ACEI), Angiotensin receptor blocker (ARB), aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
- •Oral body temperature within the range 35.0-37.5 °C
- •Able to provide written informed consent prior to study participation. .
- •Able to communicate well with the investigator and comply with the requirements of the study.
排除标准
- •Severe Hypertension Grade 3 WHO classification (Mean Sitting Diastolic Blood Pressure (MSDBP) 110 mmHg and/or Mean Sitting Systolic Blood Pressure MSSBP 180 mmHg)
- •Acetylsalicyclic acid (ASA) treatment >1g/day or regular use of Non steroidal anti-inflammatory drug (NSAIDs)
- •Kidney disease not caused by diabetes or hypertension
- •Serum potassium < 3.5 or > 5.1 mEq/L
- •GFR < 40 ml/min/1.73m2 as measured by the MDRD formula
- •Serum albumin < 2.0mg/dL
- •History of hypertensive encephalopathy or cerebrovascular accident at any time prior to Visit
- •Current diagnosis of heart failure (New York Heart Association (NYHA) Class II-IV)
- •History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
- •Second or third degree heart block without a pacemaker
- •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •Clinically significant valvular heart disease
- •Type 1 diabetes mellitus
- •Uncontrolled Type II diabetes mellitus (Hemaglobin subtype A1C (HbA1C) >11 %)
- •History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •Significant illness within the two weeks prior to dosing.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs including, but not limited to, any of the following:
- •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
- •Currently active or previously active inflammatory bowel disease during the 12 months prior to Visit 1 Currently active gastritis, duodenal or gastric ulcers, or gastrointestinal/rectal bleeding during the 3 months prior to Visit
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase Evidence of hepatic disease, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •Current treatment with cholestyramine or cholestipol resins
- •History of immunocompromise, including a positive HIV test result.
- •History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •History of drug or alcohol abuse within the 12 months prior to dosing.
- •Persons directly involved in the execution of this protocol.
- •Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
- •History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- •Known or suspected contraindications to the study medications, including history of allergy to Angiotensin converting enzyme (ACE) inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
- •Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study
- •Use of any prescription drug or over-the-counter (OTC) medication which is prohibited by the protocol.
- •Patients who previously participated in any Aliskiren study.
- •Pregnant or nursing woman.
- •Other protocol-defined inclusion/exclusion criteria may apply
结局指标
主要结局
To evaluate the time-course of the antiproteinuric effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy.
次要结局
- To investigate whether there is a change on biomarkers of inflammation and cardiovascular risk.
- To measure blood pressure changes over time during the onset and offset of effect.
研究者
研究点 (2)
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