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临床试验/jRCTs061190027
jRCTs061190027已完成不适用

Efficacy and Safety of Esaxerenone in hypertensive patients with diabetic kidney disease : a single-arm, open-label study. (EX-DKD study)

未提供0 个研究点目标入组 120 人开始时间: 2020年2月25日最近更新:
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试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
Change from baseline in blood pressure (home BP [early morning]: systolic BP)
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Single Arm Study
干预模型
Single Assignment
主要目的
Treatment Purpose
盲法
Open(masking Not Used)

入排标准

年龄范围
20age 0month 0week old over 至 85age 0month 0week old not（—）
性别
All

入选标准

  • •Subjects aged 20 to 85 years at informed consent
  • •Patients with type 2 diabetes and HbA1c < 9.0%
  • •UACR < 30 mg/gCr, or 30 =< UACR < 1,000 mg/gCr
  • •Patients with 30 mL/min/1.73 m2 =< eGFRcreat < 60 mL/min/1.73 m2
  • •Patients treated with ACEi or ARB, or, ACEi or ARB + CCB
  • •Subjects with hypertension (Office blood pressure: 130 mmHg =< Sitting SBP < 180 mmHg and/or 80 mmHg =< Sitting DBP < 110 mmHg
  • •Patients who are able to measure home BP

排除标准

  • •Secondary hypertension or malignant hypertension
  • •Patients with type 1 diabetes
  • •Patients with diabetes due to other specific mechanisms or diseases (Pancreatic exocrine disease, endocrine disease, etc.)
  • •Patients diagnosed with non-diabetic nephropathy, AND, whose prescription for steroid or immunosuppressive medication had been modified within 3 months prior to obtaining the signed informed consent, OR, will have their medication adjusted within the next 4 months (e.g. glomerulonephritis, lupus nephritis).
  • •Patients with nephrotic syndrome and active nephritis
  • •Patients with rapid exacerbation of kidney disease (serum Cr level increased by 50% or more)
  • •Patients with comorbidity or history of orthostatic hypotension
  • •Patients with a history of serious adverse events to esaxerenone, spironolactone, eplerenone, RA inhibitors or Ca antagonists
  • •Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L, etc.
  • •Patients who are or will be participating in clinical trials with intervention
  • •Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
  • •Patients whose Ankle-Brachial-Index is =< 0.9 and with symptoms caused by Arteriosclerosis obliterans
  • •Patients with cerebrocardiovascular disease
  • •Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
  • •Patients diagnosed with life expectancy within one year due to some disease
  • •Patients with a history of serious drug allergies
  • •Patients who are inappropriate for this study judged by their primary physicians because of some reasons

结局指标

主要结局

Change from baseline in blood pressure (home BP [early morning]: systolic BP)

Change from baseline in **systolic blood pressure** measured in the sitting position (home BP, early morning measurement)

Change from baseline in blood pressure (home BP [early morning]: diastolic BP)

Change from baseline in **diastolic blood pressure** measured in the sitting position (home BP, early morning measurement)

次要结局

  • Change from baseline in blood pressure (office BP and home BP[bedtime]: SBP, DBP)
  • Trend of change from baseline in blood pressure (office BP and home BP [before early morning medication and bedtime ]: systolic BP, diastolic BP and mean BP)
  • Achievement ratio of target BP levels
  • Change from baseline in UACR
  • Change from baseline in CAVI
  • PD markers (PAC, PRA), blood and urine markers (Na,K,Creatinine,protein/creatinine ratio, NT-proBNP, L-FABP, NAG, beta2-MG, AGT, 8-OHdG)
  • Adverse events, Laboratory Assessment, Vital Signs, 12-lead ECG
  • Ratio of change of eGFR
  • Percentage of study subjects with serum potassium levels:5.5 mEq/L or more, 6.0 mEq/L or more

研究者

发起方
未提供

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