Effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease
- Conditions
- type 2 diabetes and chronic kidney disease
- Registration Number
- JPRN-jRCTs021230011
- Lead Sponsor
- ode Koichi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
- Secondary Outcome Measures
Name Time Method