KCT0004233已完成未知
A multi-center, randomized, double-blinded, placebo-controlled, parallel Phase ?a clinical trial for the efficacy assessment and safety evaluation by treating CU01-1001 for 12 weeks in type 2 diabetic nephropathy patients with albuminuria.
Curacle0 个研究点目标入组 40 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 30(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1)Male/female patients aged 30 years or above
- •2)Patients diagnosed as type 2 diabetes prior to screening
- •3)Patients receiving ACE inhibitors (angiotensin-converting-enzyme inhibitor) or ARB (angiotensin II receptor blockers) for at least 8 weeks prior to screening
- •4)Patients who experienced albuminuria (albumin to creatinine ratio) 30~1,500 mg/g Cr) at least twice prior to baseline, including screening results
- •5)Patients with blood pressure = 140/90mmHg at screening
- •6)Patients with 30 = GFR (glomerular filtration rate) = 89ml/min/1.73m2 at screening
- •7)Patients with 6.5 < HbA1c = 10% at screening
- •8)Patients with hemoglobin = 10g/dL at screening
- •9)Patients who give voluntary consent to the study participation
排除标准
- •1)Patients with past medical history of acute renal failure within 12weeks prior to screening; or Increase in SCr = 0.3 mg/dL within 48 hours; or an increase in SCr = 1.5-fold from baseline (the lowest value) within 12 weeks; or urine output <0.5mg/kg/hour for 6 hours
- •2)The patients with renal disease
- •; SCr > 2.0 mg/dL or non-diabetic renal, urinary disease andnephrotic patient
- •3)Patients with medical history related liver disease and hepatic function as follows: ALT (alanine aminotransferase) or AST (aspartate aminotransferase) >2 X institutional upper limit of normal (ULN), or Total bilirubin >2 X institutional upper limit of normal (ULN)
- •4)Patients with malabsorption due to organic gastrointestinal disorder or chronic gastroenterological disorders at screening (short-bowel syndrome, active Crohn's disease, and ulcerative colitis, etc.)
- •5)Patients with acute disease (including infectious diseases) at screening and who are thought to be unable to participate in the clinical study)
- •6)Within 12 weeks of the informed consent, patients who had the diagnosis and procedures of the following cardiovascular diseases: cardiac failure (NYHA class III and IV), unstable angina pectoris, myocardial infarction, transient ischemic attack, cerebro-vascular accident, history of peripheral vascular disease or coronary artery bypass surgery, and percutaneous transluminal coronary angioplasty
- •7)Patients with history of alcohol or drug abuse
- •8)Patients with any allergic reaction to the investigational product or its components
- •9)Patients who are planning to receive dialysis or renal transplantation within 36 weeks (9 months) in the future
- •10)Patients who are expected to have lower compliance with protein-limited diets and the use of the study drug
- •11)Women who are pregnant or breastfeeding a baby
- •12)Women who are able to become pregnant and do not agree to use acceptable contraception as defined by the protocol; however, women of childbearing potential who have not gone sterility procedures can participate in the study only for negative pregnancy test, and should agree to maintain effective contraception (implants of intrauterine device or intrauterine system, double barrier contraception (condom, diaphragm, sponge or cervical cap with spermicide), oral contraceptives, sterilization, and total abstinence) throughout the study
- •13)Patients who participated in other clinical study within 4 weeks of the participation in this study
- •14)Patients who are not eligible for this study participation in the judgment of the principal investigator or sub-investigator
- •15)Patients receiving fumaric acid derivatives (topical or systemic)
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