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
LG Life Sciences India Pvt Ltd16 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2010年1月11日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 16
- 主要终点
- Improvement rating of the change of 1/ Cr (creatinine) with time in the two groups. The improvement ratings will be determined the ratio of greater than 1 as improved, the ratio equal to 1 as unchanged and the ratio lesser than 1 as aggravated.
研究概览
简要总结
This clinical study is a randomised, parallel,active controlled, open label,phase III multicenter trial evaluating the safety and efficacy of Kremezin® upon administration of 6gm/ day alongwith the standard care of therapy for 48 weeks on 232 subjects with progression of chronic kidney disease of stage 3 and 4.The primary outcome measures Improvement rating of the change of 1/ Cr (creatinine) with time period from screenng to the end of treatment schedule in the two groups. The improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups,from the period of screening to end of treatment schedule, according to the 3 - Grade criteria viz. Improved, Unchanged and Aggravated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •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
- •Received any investigational agent or participated in a clinical study with the previous 2 months
- •History of gastrointestinal disease (active gastric ulcer, inflammatory bowel diseases,hiatal hernia, active peptic ulcer, or severe GI dysmotility)
- •Obstructive urologic disease and other reversible kidney diseases
- •Chronic kidney disease due to autosomal dominant polycystic kidney disease
- •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.
- •History of previous kidney transplant
- •History of recent (within the past 1 month) accelerated or malignant hypertension
- •Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina or severe cardiac disease within the past 6 months
- •Liver cirrhosis
- •Progressive malignant disease
- •Cerebral infarction and intracranial hemorrhage within 6 months , except transient ischemic attack (TIA)
- •Uncontrolled blood sugar (HbA1c > 9%)
- •Severe anaemia, Hb <7 g/dL
- •ALT or AST > 2.5 times the upper limit of normal Life expectancy less than 12 months at the point of Randomization
- •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.
- •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,
- •Patients judged as inadequate subjects for the study by investigators such as those with markedly poor self-management.
结局指标
主要结局
Improvement rating of the change of 1/ Cr (creatinine) with time in the two groups. The improvement ratings will be determined the ratio of greater than 1 as improved, the ratio equal to 1 as unchanged and the ratio lesser than 1 as aggravated.
时间窗: Observation period (-24 weeks) to treatment period (48 weeks)
次要结局
- Improvement rating of uremic symptoms such as anorexia, halitosis, nausea and pruritis from baseline in the two groups, according to the 3 - Grade criteria viz. Improved, Unchanged and Aggravated(48 weeks)
研究者
研究点 (16)
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