JPRN-jRCTs021230011招募中4 期
Effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease - FIVE-STAR
ode Koichi0 个研究点目标入组 100 人开始时间: 2023年6月22日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients who have given their written consent to participate in this study
- •2) Patients who are 20 years of age or older at the time of consent (regardless of gender)
- •3) Patients with type 2 diabetes mellitus
- •4) Patients with chronic kidney disease who meet both of the following criteria
- •I. eGFR greater than 25 mL/min/1.73 m2 and less than 90 mL/min/1.73 m2
- •II. UACR greater than 30 mg/g.cr. and less than 3500 mg/g.cr.
- •5) Patients who have not changed their medications for type 2 diabetes and chronic kidney disease in the past 4 weeks prior to obtaining consent
排除标准
- •1) Patients who are currently taking or have taken MRAs containing finerenone in the past 4 weeks prior to obtaining consent.
- •2) Patients with a history of hypersensitivity to finerenone
- •3) Patients with HbA1c greater than 10%.
- •4) Patients with a serum potassium level of 4.9 mEq/L or higher
- •5) Patients with NYHA class II-IV HFrEF (LVEF <35%)
- •6) Patients with poorly controlled hypertension (e.g., systolic BP >170 mmHg, diastolic BP >110 mmHg, or hypertensive emergencies)
- •7) Patients with a history of ischemic stroke, acute coronary syndrome, cardiovascular surgery or percutaneous intervention, or hospitalization for worsening heart or renal failure in the past 8 weeks prior to obtaining consent
- •8) Patients with a preplanned surgical or percutaneous intervention for coronary artery reconstruction or other cardiovascular disease during the individual observation period.
- •9) Patients with a preplanned treatment such as electrical cardioversion, cardiac resynchronization therapy or pacemaker implantation during the individual observation period.
- •10) Patients with preplanned dialysis or kidney transplantation during the individual observation period.
- •11) Patients with severe hepatic dysfunction (Child-Pugh Class C)
- •12) Patients receiving itraconazole, ritonavir-containing products, atazanavir, darunavir, fosamprenavir, cobicistat-containing products, or clarithromycin, or ensitrelvir
- •13) Patients with Addison's disease
- •14) Patients with active infectious diseases
- •15) Pregnant, possibly pregnant, or lactating patients
- •16) Other patients deemed inappropriate for this study by the principal investigator or subinvestigators (e.g., patients with renal artery stenosis, one kidney, or active malignancy).
研究者
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