EUCTR2005-000361-19-DK进行中（未招募）不适用
An open-label, one-period, one-treatment study which objective is to evaluate the time course of the antiproteinuric and blood pressure lowering effect of renin inhibition with Aliskiren in patients with Type 2 diabetes suffering from incipient and/or established nephropathy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and/or female patients from 30-80 years of age with a diagnosis of Type 2 diabetes (WHO criteria).
- •2.Incipient and established diabetic nephropathy (urinary albumin excretion = 100 mg/day but = 2000 mg/day). Investigator should make an effort to have two subgroups (incipient and established nephropathy) as balance as possible, but at least 5 patients in each subgroup.
- •3.GFR = 40 ml/min (estimated using MDRD formula) in the last 4 months.
- •4.Female patients must be postmenopausal (i.e. must have had no regular menstrual bleeding for at least 1 years prior to inclusion) or must have had a bilateral oophorectomy or must have been surgically sterilized or hysterectomized at least 6 months prior to screening. Menopause will be confirmed by a plasma 17ß-estradiol concentration of <20 pg/mL and a plasma FSH level of >40 IU/L. Surgical sterilization procedures or hysterectomy must be supported with clinical documentation made available to the sponsor.
- •5.To be eligible patients must fulfill the following criteria
- •a) 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).
- •b) Newly diagnosed hypertensive patients must have a blood pressure = 135/85 mm Hg but lower than 170/105 mm Hg at baseline (Day -1).
- •6.Patients must be on stable hypoglycemic medications for at least 8 weeks prior to Visit 2 ( Day -1).
- •7.Patients must be willing and medically able to discontinue all ACEI, ARB, aldosterone receptor antagonist and potassium sparing diuretic medications for the duration of the study.
- •8.Oral body temperature within the range 35.0-37.5 °C
- •9.Able to provide written informed consent prior to study participation.
- •Patient information and consent forms generated by the investigator must be approved by the sponsor prior to submission to the Ethics Committee (EC)/Institutional Review Board (IRB). A copy of the patient information and consent forms approved by the EC/IRB must be forwarded to the sponsor prior to study initiation.
- •10.Able to communicate well with the investigator and comply with the requirements of the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients meeting any of the following criteria during screening or baseline evaluations will be excluded from entry into or continuation in the study:
- •1.Severe Hypertension Grade 3 WHO classification (MSDBP ? 110 mmHg and/or MSSBP ? 180 mmHg)
- •2.ASA treatment >1g/day or regular use of NSAIDs
- •3.Kidney disease not caused by diabetes or hypertension
- •4.Serum potassium < 3.5 or > 5.1 mEq/L
- •5.GFR < 40 ml/min/1.73m2 as measured by the MDRD formula
- •6.Serum albumin < 2.0mg/dL
- •7.History of encephalopathy at any time prior to visit 1.
- •Cerebrovascular accident in the last 12 months prior to Visit1.
- •8.Current diagnosis of heart failure (NYHA Class II-IV)
- •9.History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention (PCI) during the 6 months prior to Visit 1
- •10.Second or third degree heart block without a pacemaker
- •11.Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia
- •12.Clinically significant valvular heart disease
- •13.Type 1 diabetes mellitus
- •14.Uncontrolled Type II diabetes mellitus (HbA1C >11 %)
- •15.History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years
- •16.Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation.
- •17.Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
- •18.Significant illness within the two weeks prior to dosing.
- •19.Significant illness within the two weeks prior to dosing.
- •20.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 1.
- •Any history of pancreatic injury, pancreatitis or evidence of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
- •Evidence of hepatic disease as determined by any one of the following: SGOT/AST or SGPT/ALT values exceeding 2 x ULN at Visit 1, and Gamma GT x 3 ULN at Visit 1 a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt
- •Current treatment with cholestyramine or cholestipol resins
- •21.History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.
- •22.History of a positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- •23.History of drug or alcohol abuse within the 12 months prior to dosing.
- •24.Persons directly involved in the execution of this protocol.
- •25.Any condition that in the opinion of the investigator or the Novartis medical monitor would jeopardize the evaluation of efficacy or safety
- •26.History of noncompliance to medical regimens or unwillingness to comply with the study protocol
- •27.Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors and/or to thiazide diuretics or other sulfonamide derived drug
- •28.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 t
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