NCT03550859Unknown4 期
Randomized, Open, Multicenter Study to Evaluate the Renal Function of HMG-CoA Reductase add-on in Chronic Kidney Disease Patients With Proteinuria
Yuhan Corporation16 个研究点 分布在 1 个国家目标入组 374 人开始时间: 2018年6月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 374
- 试验地点
- 16
- 主要终点
- Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
研究概览
简要总结
This study is to evaluate the renal function of HMG-CoA reductase add-on in chronic kidney disease patients with proteinuria.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 19 years
- •Chronic Kidney Disease (CKD) with CKD stage G2 or G3 and 300 mg/g ≤ urine PCR ≤ 3000 mg/g
- •Diagnosed with hypertension
- •Written informed consent
- •Patients who have not administered statin (including rosuvastatin) and hyperlipidemia treatment for at least 4 weeks prior to randomization
排除标准
- •Type I diabetes
- •Uncontrolled diabetic patients with HbA1c > 10% at screening
- •Hypertensive patients whose mean blood pressure was not controlled at 160/90 mmHg or more in triplicate despite the use of antihypertensive agents at the time of randomization
- •Calculated LDL-C ≥ 160 mg/dL at randomization
- •Patients who have taken RAS blockers (ACE inhibitor, ARB, and Aldosterone antagonist) for 4 weeks prior to randomization
- •Heart failure patients with NYHA class IV
- •Patients with acute and chronic liver disease, acute inflammation, hematologic abnormalities and cancer within the last 6 months
- •Patients with a history of cerebral blood cardiovascular complications (cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass, and percutaneous coronary intervention)
- •Patients taking immunosuppressive drugs
- •Patients undergoing eGFR <30 mL/min/1.73 m2 (CKD-EPI formula) or renal replacement therapy (dialysis or renal transplant) at screening
- •Patients with a change in eGFR (CKD-EPI formula) value showing a difference of more than 30% in the last 6 months at screening
- •Creatine kinase (CK) level ≥ 3x ULN (upper limit of normal range)
- •Patients who are pregnant or planning to become pregnant
- •Contraindications stated in the SPC of telmisartan or rosuvastatin
- •Those participating in other clinical trials for investigational products at screening
- •Patients deemed to be ineligible to participate in the trial by investigator
研究组 & 干预措施
Duowell Tab. 40/10mg
Experimental
Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
干预措施: Telmisartan/Rosuvastatin 40/10mg (Drug)
Micardis Tab. 40mg
Active Comparator
Telmisartan 40mg qd for 48 weeks
干预措施: Telmisartan 40mg (Drug)
结局指标
主要结局
Rate of change from baseline to week 48 in Urine Protein to Creatinine Ratio (UPCR)
时间窗: baseline, week 48
次要结局
- Change from baseline to week 48 in urine nephrin(baseline, week 48)
- Change from baseline to week 48 in high-sensitivity CRP (hs-CRP)(baseline, week 48)
- Proportion of subjects whose UPCR decreased by more than 30% at 48 weeks(baseline, week 48)
- Change from baseline to week 24 and week 48 in Urine Albumin-to-Creatinine Ratio (UACR)(baseline, week 24, week 48)
- Change from baseline to week 48 in UPCR(baseline, week 48)
- Change from baseline to week 48 in HOMA-insulin resistance (HOMA-IR)(baseline, week 48)
- Change from baseline to week 24 in UPCR(baseline, week 24)
- Change from baseline to week 48 in MCP-1 (monocyte chemoattractant protein 1)(baseline, week 48)
- Proportion of subjects who received renal replacement therapy (dialysis or renal transplant) at 12, 24, 36, or 48 weeks(baseline, week 12, week 24, week 36, week 48)
- Change from baseline to week 24 and week 48 in estimated glomerular filtration rate (eGFR)(baseline, week 24, week 48)
- Change from baseline to week 48 in 24hr urine protein(baseline, week 48)
- Change from baseline to week 48 in urinary 8-isoprostane(baseline, week 48)
- Change from baseline to week 48 in type IV collagen(baseline, week 48)
研究者
研究点 (16)
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