CTRI/2010/091/000349已完成3 期
A randomized, multicentre, parallel, open label, active controlled, phase III study to evaluate the clinical efficacy and safety of Kremezin® on suppression of Progression of Chronic Renal Failure
G Life Sciences India Pvt Ltd0 个研究点目标入组 232 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •A. Outpatients only of either sex of 18-70 years
- •B. CKD Stage 3, 4 (GFR by Cockcroft Gault equation 15-59 mL/min 1.73M2)
- •C. Blood pressure that is well controlled during the observation period
- •D. Willing and able to give informed consent and comply with study procedures.
排除标准
- •1. Received any investigational agent or participated in a clinical study with the previous 2 months
- •2. History of gastrointestinal disease (active gastric ulcer, inflammatory bowel diseases,hiatal hernia, active peptic ulcer, or severe GI dysmotility)
- •3. Obstructive urologic disease and other reversible kidney
- •4. Chronic kidney disease due to autosomal dominant polycystic kidney disease
- •5. 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.
- •6. History of previous kidney transplant
- •7. History of recent (within the past 1 month) accelerated
- •or malignant hypertension
- •8. Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months
- •9. Liver cirrhosis
- •10. Patients with active infection, uncontrolled inflammatory disease
- •11. Progressive malignant disease
- •12. Cerebral infarction and intracranial hemorrhage within 6 months , except transient ischemic attack (TIA)
- •13. Uncontrolled blood sugar (HbA1c > 9%)
- •14. Severe anaemia, Hb <7 g/dL
- •15. ALT or AST > 2.5 times the upper limit of normal
- •Life expectancy less than 12 months at the point of Randomization
- •16. Received immunosuppressive therapy (including systemic
- •corticosteroids for more than 5days at a daily dose in excess of 0.1 mg/kg, prednisolone equivalent) in the past 3 months, or anticipated to require such treatment during the study course.Pregnant patients and willing to bear child during study. 17. Patient with marked changes in diseases status such as cases with abnormally high levels of blood pressure (diastolic pressure 120 mm Hg or over) or unstable levels,
- •18. Patients judged as inadequate subjects for the study by investigators such as those with markedly poor self-management.
研究者
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