Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in CAVI
研究概览
简要总结
To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.
详细描述
Finerenone is a novel non-steroidal selective mineralocorticoid receptor antagonist (MRA), characterized by a higher selectivity and affinity for mineralocorticoid receptors than conventional steroidal MRA. In the international phase III trials (FIDELIO-DKD and FIGARO-DKD), finerenone reduced the risk of progression of nephropathy and cardiovascular events in chronic kidney disease (CKD) patients with type 2 diabetes (T2D) who had been on standard treatment for CKD and T2D. However, the possible mechanistic insights into clinical benefits of finerenone in that patient population are currently very limited. To address them, in this investigator-initiated, multicenter, placebo-controlled, randomized trial (FIVE-STAR), the investigators seek to assess the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with T2D and CKD.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given their written consent to participate in this study
- •Patients who are 20 years of age or older at the time of consent (regardless of gender)
- •Patients with type 2 diabetes mellitus
- •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.
- •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
- •Patients who are currently taking or have taken MRAs containing finerenone in the past 4 weeks prior to obtaining consent.
- •Patients with a history of hypersensitivity to finerenone
- •Patients with HbA1c greater than 10%.
- •Patients with a serum potassium level of 4.9 mEq/L or higher
- •Patients with NYHA class II-IV HFrEF (LVEF <35%)
- •Patients with poorly controlled hypertension (e.g., systolic BP >170 mmHg, diastolic BP >110 mmHg, or hypertensive emergencies)
- •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
- •Patients with a preplanned surgical or percutaneous intervention for coronary artery reconstruction or other cardiovascular disease during the individual observation period.
- •Patients with a preplanned treatment such as electrical cardioversion, cardiac resynchronization therapy or pacemaker implantation during the individual observation period.
- •Patients with preplanned dialysis or kidney transplantation during the individual observation period.
- •Patients with severe hepatic dysfunction (Child-Pugh Class C)
- •Patients receiving itraconazole, ritonavir-containing products, atazanavir, darunavir, fosamprenavir, cobicistat-containing products, or clarithromycin, or ensitrelvir
- •Patients with Addison's disease
- •Patients with active infectious diseases
- •Pregnant, possibly pregnant, or lactating patients
- •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).
研究组 & 干预措施
Finerenone
Kerendia® tablets
干预措施: Finerenone (Drug)
Placebo
Placebo tablets
干预措施: Placebo (Drug)
结局指标
主要结局
Change in CAVI
时间窗: 24 weeks
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
次要结局
- Change in urinary beta2-MG(24 weeks)
- Change in urinary NAG(24 weeks)
- Change in UACR(12 weeks, 24 weeks)
- Change in pentosidine(24 weeks)
- Change in urinary alpha1-MG(24 weeks)
- Change in urinary NGAL(24 weeks)
- Change in urinary type IV collagen(24 weeks)
- Change in urinary L-FABP(24 weeks)