EUCTR2005-004989-17-IT进行中（未招募）不适用
A PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF AST-120 FOR PREVENTION OF CHRONIC KIDNEY DISEASE PROGRESSION IN PATIENTS WITH MODERATE TO SEVERE CHRONIC KIDNEY DISEASE - ND
KUREHA CORPORATIO0 个研究点目标入组 800 人开始时间: 2007年12月10日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 800
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) Age 18 years or older; 2) Moderate to severe CKD (sCr >= 2.0 mg/dL (>=177 umol/L) and <= 5.0 mg/dL (<= 442 umol/L), not anticipated to require dialysis or renal transplant within the next 6 months; 3) Patient survival expected to be no less than one year; 4) Serum creatinine >= 2.0 mg/dL (>= 177 umol/L) and <= 5.0 mg/dL (<= 442 umol/L) at the initial Screening visit; 5) Proteinuria / Progressive deterioration in renal function: Urinary total protein to urinary total creatinine ratio (both values measured as mg/dL, or other like units) must be > 0.5 on a spot void obtained at the Screening visit OR If the urinary total protein to urinary total creatinine ratio is <0.5, then the patient may return for a second Screening visit 3 months later. If the sCr value at the second Screening visit is >10% higher than the first Screening visit but not > 5.0 mg/dL (> 442 umol/L) or if the urinary total protein to urinary total creatinine ratio is > 0.5, then the patient may be enrolled 6) Sitting blood pressure <= 160/90 mmHg at both Screening and Baseline visits. In addition, blood pressure, if measured, must have been stable in hypertensive patients over the 3 months prior to Screening, with no more than 1 blood pressure reading > 160/90 mmHg; 7) In patients being treated for hypertension, they should be on a stable anti-hypertensive regimen, defined as no changes in anti hypertensive medications or doses in the last 3 months prior to the Baseline visit, and to include if medically indicated, a stable dose of either an ACEI or ARB; 8) Stable nutritional status; and 9) Willingness to comply with the study and sign a written informed consent.
- •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
- •1) Obstructive or reversible cause of kidney disease; 2) Severe nephrotic syndrome defined as a ratio of urinary total protein to urinary creatinine (both components measured as mg/dL or other like units) of > 6.0 as measured on a spot void; 3) Adult polycystic kidney disease; 4) History of previous kidney transplant; 5) History of alcohol or drug abuse within the past 12 months; 6) Known human immunodeficiency virus (HIV) infection; 7) Received immunosuppressive therapy (including systemic corticosteroids for more than 5 days at a daily dose in excess of 0.1 mg/kg, prednisone equivalent) in the past 3 months, or anticipated to require such treatment during the study course; 8) History of recent (within the past 6 months) accelerated or malignant hypertension; 9) Patients who are likely to require changes in ACEI or ARB regimens during the course of this study; 10) Uncontrolled arrhythmia or severe cardiac disease (New York Heart Association Class III - IV), including myocardial infarction, percutaneous coronary intervention, coronary artery bypass graft, cerebrovascular accident, or transient ischemic attack within the past 6 months; 11) History of malabsorption, inflammatory bowel disease, active peptic ulcer, or severe GI dysmotility, not attributable to the use of a phosphate binder; 12) History of cancer within the past 5 years (cervical carcinoma in situ, low grade cutaneous malignancy, or other low grade malignancy are exemptions); 13) Alanine transaminase (ALT) or aspartate transaminase (AST) values > 2.5 times the upper limit of normal (ULN);
研究者
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