JPRN-jRCTs061190027已完成未知
Efficacy and Safety of Esaxerenone in hypertensive patients with diabetic kidney disease : a single-arm, open-label study. - EX-DKD study
Wada Jun0 个研究点目标入组 113 人开始时间: 2019年12月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 113
研究概览
简要总结
In hypertensive patients with DKD inadequately controlled by RASi or RASi plus CCB, esaxerenone demonstrated a BP-lowering effect and improvement in albuminuria. The beneficial effects were consistent regardless of the severity of albuminuria. Additionaly, esaxerenone can be used safely without clinically relevant serum potassium elevation and eGFR reduction. Esaxerenone may be a suitable antihypertensive treatment option for hypertensive patients with DKD with moderately renal impairment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 85age old（—）
- 性别
- All
入选标准
- •1)Subjects aged 20 to 85 years at informed consent
- •2)Patients with type 2 diabetes and HbA1c < 9.0%
- •3)UACR < 30 mg/gCr, or 30 =< UACR < 1,000 mg/gCr
- •4)Patients with 30 mL/min/1.73 m2 =< eGFRcreat < 60 mL/min/1.73 m2
- •5)Patients treated with ACEi or ARB, or, ACEi or ARB + CCB
- •6)Subjects with hypertension (Office blood pressure: 130 mmHg =< Sitting SBP < 180 mmHg and/or 80 mmHg =< Sitting DBP < 110 mmHg
- •7)Patients who are able to measure home BP
排除标准
- •1)Secondary hypertension or malignant hypertension
- •2)Patients with type 1 diabetes
- •3)Patients with diabetes due to other specific mechanisms or diseases (Pancreatic exocrine disease, endocrine disease, etc.)
- •4)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).
- •5)Patients with nephrotic syndrome and active nephritis
- •6)Patients with rapid exacerbation of kidney disease (serum Cr level increased by 50% or more)
- •7)Patients with comorbidity or history of orthostatic hypotension
- •8)Patients with a history of serious adverse events to esaxerenone, spironolactone, eplerenone, RA inhibitors or Ca antagonists
- •9)Hyperkalemia patients, patients whose serum potassium level exceeds 5.0 mEq/L, etc.
- •10)Patients who are or will be participating in clinical trials with intervention
- •11)Pregnant, possibly pregnant, breast-feeding or planning to become pregnant during the study
- •12)Patients whose Ankle-Brachial-Index is =< 0.9 and with symptoms caused by Arteriosclerosis obliterans
- •13)Patients with cerebrocardiovascular disease
- •14)Patients with severe liver dysfunction (liver failure, cirrhosis, etc.)
- •15)Patients diagnosed with life expectancy within one year due to some disease
- •16)Patients with a history of serious drug allergies
- •17)Patients who are inappropriate for this study judged by their primary physicians because of some reasons
研究者
相似试验
已完成
不适用
ESES-LVH studyJPRN-jRCTs071190043Tsujita Kenichi60
已完成
不适用
ENaK studyHypertensionJPRN-jRCTs031210273Katsuya Tomohiro126
已完成
3 期
Study of CS-3150 in Patients With Essential HypertensionEssential HypertensionNCT02890173Daiichi Sankyo Co., Ltd.1,001
已完成
1 期
Clinical Pharmacology Study of CS-3150 Evaluation of the effect of repeated dose of itraconazole orally administered to healthy Japanese adult male on the pharmacokinetics of CS-3150Healthy volunteersJPRN-jRCT2080223231DAIICHI SANKYO Co.,Ltd.20
已完成
3 期
A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.Hypertension, Diabetes MellitusNCT00219089Novartis839