NCT01893242撤回3 期
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE THE RISK OF END STAGE RENAL DISEASE AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (ALERENAL STUDY)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
研究概览
简要总结
This randomized, double-blind, placebo-controlled study will evaluate the potential of aleglitazar to reduce the risk of end stage renal disease and cardiovascular mortality in patients with type 2 diabetes mellitus and chronic kidney disease. Patients will be randomized to receive oral daily doses of aleglitazar or matching placebo. The anticipated time on study treatment is approximately 3 years.
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
- Double (Participant, Investigator)
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
- •Adult patients >= 18 years of age at screening
- •Diagnosis of diabetes mellitus Type 2
- •Glycosylated hemoglobin A1C (HbA1C) < 10% at screening
- •Estimated glomerular filtration rate (eGFR) >=30 and < 60 mL/min/1.73 m2
- •Urinary albumin-to-creatinine ratio (UACR) >=500 and < 5000 mg/g
- •Treatment with either angiotensin converting enzyme inhibitor or angiotensin II receptor blocker for at least three months prior to screening
- •Women of child-bearing potential using a highly effective birth control method must be willing to use the same method of contraception during the entire course of the study
排除标准
- •Treatment with a PPARgamma agonist and/or PPARalpha agonist in the last 12 weeks screening
- •Prior intolerance to a TDZ or fibrate
- •Previous participation in a trial with aleglitazar
- •Diagnosis or history of other types of diabetes
- •Diagnosis or history of acute metabolic diabetic complications within the past 6 months
- •Known primary glomerulonephritis, secondary glomerulonephritis other than diabetic nephropathy or polycystic kidney disease
- •Diagnosed acute kidney injury or dialysis within 12 weeks prior to screening
- •Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg at baseline)
- •Known secondary hypertension due to renal artery stenosis, primary aldosteronism, or pheochromocytoma
- •History of myocardial infarction or stroke in the past 12 weeks prior to screening
- •Symptomatic congestive heart failure NYHA class II-IV at baseline or heart failure leading to hospitalization within the 12 months prior to screening
- •Diagnosed and/or treated malignancy (except for treated cases of basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years
- •Inadequate liver and hematological function
- •Chronic treatment with immunosuppressive therapy
- •Women who are pregnant, intending to become pregnant during the study period, currently lactating females, or women of child-bearing potential not using highly effective birth control methods
研究组 & 干预措施
Aleglitazar Arm
Experimental
干预措施: Aleglitazar (Drug)
Placebo Arm
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time to the first occurrence of either component of the composite endpoint: end stage renal disease or cardiovascular death
时间窗: Approximately 5 years
次要结局
- Time to the first occurrence of any component of major adverse cardiovascular event composite (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)(Approximately 5 years)
- Time to the first occurrence of any component of macrovascular composite (CV death, non fatal myocardial infarction, hospitalization for unstable angina, non fatal stroke)(Approximately 5 years)
- Time to the first occurrence of any component of composite outcome of end-stage renal disease and all-cause mortality(Approximately 5 years)
研究者
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