NCT01968668已完成2 期
A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Japanese Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 96
- 主要终点
- Change of urinary albumin-to creatinine ratio
研究概览
简要总结
This study will be conducted in Japanese subjects with type 2 diabetes mellitus and the clinical diagnosis of Diabetic Nephropathy( DN) using a multi-center, randomized, adaptive, double-blind, placebo-controlled, parallel-group design.
Primary objective of the study is investigate the change of Urinary Albumin to Creatine Ratio (UACR) after treatment with different oral doses of BAY94-8862 given once daily from baseline to Visit 8 (Day 90)
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, Care Provider, 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
- •Japanese subjects with type 2 diabetes mellitus and a clinical diagnosis of DN (Diabetic Nephropathy) treated with at least the minimal recommended dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) and/or Angiotensin Receptor Blocker (ARB)
- •Subjects with a clinical diagnosis of Diabetic Nephropathy (DN) based on at least 1 of the following criteria:
- •Persistent very high albuminuria defined as Urinary Albumin to Creatine Ratio (UACR) of >/=300 mg/g (>/=34 mg/mmol) in 2 out of 3 first morning void samples and estimated glomerular filtration rate (eGFR) >/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) or
- •Persistent high albuminuria defined as UACR of >/=30 mg/g but <300 mg/g (>/=3.4 mg/mmol but <34 mg/mmol) in 2 out of 3 first morning void samples and eGFR>/=30 mL/min/1.73 m2 but <90 mL/min/1.73 m2 (CKD-EPI)
- •Serum potassium </=4.8 mmol/L at both the run-in visit and the screening visit
排除标准
- •Non-diabetic renal disease (confirmed by biopsy)
- •Known bilateral clinically relevant renal artery stenosis (>75%)
- •Glycated hemoglobin(HbA1c) >12% at the run-in visit or the screening visit
- •UACR >3000 mg/g (339 mg/mmol) in any of the urinary first morning void samples at the run-in visit or screening visit
- •Hypertension with mean sitting systolic blood pressure (SBP) >/=180 mmHg or mean sitting diastolic blood pressure (DBP) >/=110 mmHg at the run-in visit or mean sitting SBP >/=160 mmHg or mean sitting DBP >/=100 mmHg at the screening visit
- •Subjects with a clinical diagnosis of heart failure with reduced ejection fraction (HFrEF) and persistent symptoms (New York Heart Association class II-IV) at the run-in visit
- •Concomitant therapy with eplerenone, spironolactone, any renin inhibitor, or potassium-sparing diuretic
研究组 & 干预措施
BAY94-8862 (2.5 mg)
Experimental
干预措施: BAY94-8862 (Drug)
BAY94-8862 (1.25 mg)
Experimental
干预措施: BAY94-8862 (Drug)
BAY94-8862 (5 mg )
Experimental
干预措施: BAY94-8862 (Drug)
BAY94-8862 (7.5 mg)
Experimental
干预措施: BAY94-8862 (Drug)
BAY94-8862 (10 mg)
Experimental
干预措施: BAY94-8862 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
BAY 94-8862 (15 mg)
Experimental
干预措施: BAY 94-8862 (Drug)
BAY 94-8862 (20 mg)
Experimental
干预措施: BAY 94-8862 (Drug)
结局指标
主要结局
Change of urinary albumin-to creatinine ratio
时间窗: Baseline and 90 days
次要结局
- Change in serum potassium concentration(Baseline and 90 days)
研究者
相似试验
已完成
2 期
A Dose-Finding Study in Japanese Patients to Evaluate the Effect of Obicetrapib as an Adjunct to Stable Statin Therapy.High CholesterolHypercholesterolemiaDyslipidemiaNCT05421078NewAmsterdam Pharma102
Unknown
2 期
A Study to Evaluate the Effect of BioK+ 50B® on Glycemic Control in a Type 2 Diabetes PopulationType2 DiabetesNCT03239366Bio-K Plus International Inc.130
已完成
1 期
Safety And Tolerability Of Escalating Intravenous Doses Of PF-05231023 In Adult Subjects With Type 2 DiabetesDiabetes Mellitus, Type 2NCT01285518Pfizer84
终止
3 期
Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints (Core and Extension Phases)Type 2 Diabetes MellitusCardiovascular DiseaseNCT00549757Novartis Pharmaceuticals8,606
已完成
2 期
Out-Patient Study in Patients With Type 2 Diabetes Mellitus Who Are Taking no Diabetes Medication or Metformin OnlyDiabetes Mellitus, Type 2NCT00518115GlaxoSmithKline361