NCT02358096已完成2 期
A Phase 2, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 57
- 主要终点
- Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD) at 12 weeks compared to placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have an estimated glomerular filtration rate (eGFR) ) >=25 and <75 ml/min/1.73m
- •Subject must have a documented diagnosis of T2DM and received anti-diabetic medication (oral and/or parenteral) for at least 1 year prior to screening
- •Subject's glycated hemoglobin (HbA1c) level is < 11.0% (<97 mmol/mol) at screening.
- •Subject is on a stable therapy with an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin receptor blockers (ARB) for at least 3 months prior to screening.
- •Subject who receives anti-hypertensive treatment, non-insulin anti-diabetic agents and/or vitamin D receptor activators at screening needs to be on stable therapy for at least 3 months prior to screening. Subjects on insulin therapy may have the insulin type/dose/schedule adjusted even during the 3 months prior to screening.
- •If the subject has been subjected to specific dietary interventions then this has to be stable over the past 3 months prior to screening visit.
- •Subject's UACR is ≥ 200 and ≤ 3000 mg/g in a first morning void (FMV) sample at screening AND the geometric mean UACR of all FMV samples at visit 4 and at visit 5 is ≥ 200 and ≤ 3000 mg/g AND the UACR in at least 3 FMV samples at visit 4 and visit 5 is ≥ 200 mg/g.
排除标准
- •Subject is on, or previously received, renal replacement therapy (e.g. dialysis or kidney transplantation).
- •Subject has obstructive uropathy or other causes of renal impairment not related to parenchymal renal disorder and/or disease of the kidney; or subject currently has or has had in the past renal disease secondary to malignancy.
- •Subject's renal impairment and/or albuminuria is considered to be of other origin than Diabetic Kidney Disease.
- •Subject has known (auto-) immune disorder and/or received immunosuppression for more than 2 weeks, cumulatively, within 12 weeks prior to screening or anticipated need for immuno-suppressive therapy during the study.
- •Subject has active urinary tract infection which requires treatment or clinically significant infection at the time of screening or randomization
- •Subject is diagnosed with type 1 diabetes mellitus or diabetes mellitus with unclear etiology.
- •Subject has a sitting systolic blood pressure (SBP) <90 or >160 mmHg and/or a diastolic blood pressure (DBP) >90 mmHg at screening.
研究组 & 干预措施
ASP8232
Experimental
ASP8232 administered once daily
干预措施: ASP8232 (Drug)
Placebo
Placebo Comparator
Placebo administered once daily
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change of log transformed urinary albumin to creatinine ratio (UACR) from baseline to end of treatment
时间窗: Baseline and end of treatment (12 weeks)
次要结局
- Mean change of log transformed albumin excretion rate (AER) from baseline to end of treatment(Baseline and end of treatment (12 weeks))
- Proportion of subjects with either >30% or >40% or >50% reduction in AER from baseline to end of treatment(Baseline and end of treatment (12 weeks))
- Proportion of subjects with either >30% or >40% or >50% reduction in UACR from baseline to end of treatment(Baseline and end of treatment (12 weeks))
研究者
研究点 (57)
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