NCT02681952已完成4 期
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Preference of formulation
研究概览
简要总结
A Multicenter, Randomized, Open-labeled, Cross-over, Active-controlled, Phase IV Clinical Trial to Evaluate the Preference of Formulation and the Efficacy and Safety of Renamezin and Kremezin in Pre-dialysis Patients With Chronic Renal Failure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pre-dialysis patients with chronic renal failure stage
- •patient for holding the stable state in serum creatinine 2.0mg/dl - 5.0mg/dl of MDRD GFR 15-60ml/min/1.73m2 for 3 months before screening
- •patients haven't experienced dose spherical carbon adsorbent for 3months before screening
- •patients who were no noticeable change for 4weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(type of blood pressure medication and dose -related, diet therapy)
- •patients spontaneously written consent to participate in this clinical trial
排除标准
- •patients with passes through the digestive tract disorders
- •patients with uncontrolled constipation symptoms
- •kidney transplant patients
- •patients who are taking immunosuppressive drugs
- •patients suffering from digestive tract ulcers and esophageal varices
- •patients with uncontrolled hypertension
- •patients hospitalized with cardiovascular disease within 3 months of the screening
- •patients with current infections
- •patients who do not fulfill therapies of chronic renal failure (taking medicine and diet) as appropriate
- •patients with hepatic impairment (2.5 times greater than the upper limit of normal levels of AST, ALT)
- •uncontrolled diabetes (HbA1c > 10 % or a fasting glucose > 180mg / dL)
- •patients with malignant tumors (However, if you do not relapse within five years after completion of therapy can be registered)
- •pregnant women, nursing mothers
- •those who do not agree to a contraceptive method allowed for the possibility of pregnancy in women
- •patients participating in another clinical trial in addition to the current clinical trial
- •subjects with dependency on drugs or alcohol
- •subjects who took any other investigational drugs within 30 days before participating this clinical trial study
- •patients expected to starting the dialysis within three months
- •other patients deemed unsuitable tester
研究组 & 干预措施
Kremezin->Renamezin
Active Comparator
干预措施: Kremezin granule (Drug)
Renamezin->Kremezin
Active Comparator
干预措施: Renamezin capsule (Drug)
Renamezin->Kremezin
Active Comparator
干预措施: Kremezin granule (Drug)
Kremezin->Renamezin
Active Comparator
干预措施: Renamezin capsule (Drug)
结局指标
主要结局
Preference of formulation
时间窗: 24weeks
questionnaire
次要结局
- estimated GFR(Glomerular Filtration Rate)(12weeks, 24weeks)
- Serum Indoxyl sulfate(12weeks, 24weeks)
- Cystatin-C(12weeks, 24weeks)
- Serum Creatinine(12weeks, 24weeks)
研究者
研究点 (1)
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