NCT00860431已完成4 期
K-STAR (Kremezin STudy Against Renal Disease Progression in Korea) Randomized, Open-label, Controlled Study
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
- 578
- 试验地点
- 1
- 主要终点
- The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy)
研究概览
简要总结
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) added to standard-of-care therapy in moderate to severe Chronic Kidney Disease (CKD III-IV), on time to first occurrence of any event of the triple composite outcome of initiation of renal replacement therapy, decline of eGFR 50% or more or doubling of serum creatinine (sCr) when compared with standard-of-care group;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to GFR and proteinuria;
- To evaluate the effectiveness of AST-120 (spherical carbon adsorbent) to health related quality of life;
- To evaluate the safety and tolerability of long-term AST-120 therapy in patients with CKD;
- To evaluate the all-cause mortality and hospitalization apart from those planned for operation and intervention)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Age 18 years or older
- •CKD stage 3,4 (estimated GFR by Cockcroft-Gault equation 15-59 mL/min/1.73m^2)
- •Followed up by responsible nephrologists more than 6 months
- •eGFR checked 2 times or more during screening period
- •eGFR declined or expected to decline >= 5mL/min/year or >=2.5mL/min/6 months
- •Blood pressure <= 160/100 mmHg
- •Blood pressure checked 3 times or more during screening period
- •No significant change of medication for CKD
排除标准
- •Patients who took medicine AST-120 or ketosteril within 2 months
- •Received any investigational agent or participated in a clinical study within the previous 2 months
- •History of gastrointestinal disease (active gastric ulcer, inflammatory bowel disease, hiatal hernia, or severe GI dysmotility)
- •obstructive urologic disease and other reversible kidney diseases
- •chronic kidney disease due to autosomal dominant polycystic kidney disease, ADPKD
- •severe nephrotic syndrome, 10g or more/day(or random urine pCR >= 10.0)
- •History of previous kidney transplant
- •Heart failure (NYHA III-IV), uncontrolled arrhythmia, unstable angina
- •Liver cirrhosis (Child-Pugh B,C)
- •active infection, uncontrolled inflammatory disease
- •progressive malignant disease
- •cerebral infarction and intracranial hemorrhage within 6 months,except transient ischemic attack (TIA)
- •uncontrolled blood sugar (HbA1c >10%)
- •severe anemia, Hb <7g/dL
- •Life expectancy less than 12 months at the point of randomization
- •Pregnant and willing to bear child during study
- •patients, inappropriate to study (researchers decided)
研究组 & 干预措施
2
Experimental
AST-120 6g/day (3 times a day)
干预措施: AST-120 (Drug)
结局指标
主要结局
The development of a component of a triple composite endpoint (doubling of serum Cr, decline of estimated GFR 50% or more by C-G equation, initiation of renal replacement therapy)
时间窗: approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up)
次要结局
- change of estimated GFR and urine protein excretion, Assessment of health related quality of life, all-cause mortality(approximately 49 months (at least 12 months for enrollment and 36 months for intervention, 1month for follow up))
研究者
研究点 (1)
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