Clinical trial NCT05887817: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
Official title: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Type 2 Diabetes
Chronic Kidney Diseases
Keywords: Finerenone
Vascular Stiffness
Biomarker
Lead sponsor: Saga University
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Change in CAVI
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in UACR
timeFrame: 12 weeks, 24 weeks
measure: Change in pentosidine
timeFrame: 24 weeks
measure: Change in urinary type IV collagen
timeFrame: 24 weeks
measure: Change in urinary alpha1-MG
timeFrame: 24 weeks
measure: Change in urinary beta2-MG
timeFrame: 24 weeks
measure: Change in urinary NGAL
timeFrame: 24 weeks
measure: Change in urinary NAG
timeFrame: 24 weeks
measure: Change in urinary L-FABP
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Saga
country: Japan
facility: Saga University Hospital
Study officials:
affiliation: Saga University Hospital
name: Koichi Node, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: