search
Back to results

Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR) (FIVE-STAR)

Primary Purpose

Type 2 Diabetes, Chronic Kidney Diseases

Status
Recruiting
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Finerenone
Placebo
Sponsored by
Saga University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Finerenone, Vascular Stiffness, Biomarker

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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).

Sites / Locations

  • Saga University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Finerenone

Placebo

Arm Description

Kerendia® tablets

Placebo tablets

Outcomes

Primary Outcome Measures

Change in CAVI
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline

Secondary Outcome Measures

Change in UACR
Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint)
Change in pentosidine
Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline
Change in urinary type IV collagen
Proportional changes in geometric mean of urinary type IV collagen at 24 weeks post-protocol treatment compared to baseline
Change in urinary alpha1-MG
Proportional changes in geometric mean of urinary alpha1-MG at 24 weeks post-protocol treatment compared to baseline
Change in urinary beta2-MG
Proportional changes in geometric mean of urinary beta2-MG at 24 weeks post-protocol treatment compared to baseline
Change in urinary NGAL
Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline
Change in urinary NAG
Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline
Change in urinary L-FABP
Proportional changes in geometric mean of urinary L-FABP at 24 weeks post-protocol treatment compared to baseline

Full Information

First Posted
May 24, 2023
Last Updated
October 2, 2023
Sponsor
Saga University
search

1. Study Identification

Unique Protocol Identification Number
NCT05887817
Brief Title
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
Acronym
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 7, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Saga University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Chronic Kidney Diseases
Keywords
Finerenone, Vascular Stiffness, Biomarker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Finerenone
Arm Type
Experimental
Arm Description
Kerendia® tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets
Intervention Type
Drug
Intervention Name(s)
Finerenone
Other Intervention Name(s)
Kerendia
Intervention Description
Study participants will be instructed to take either finerenone or placebo orally once daily (preferably at approximately the same time every during the morning). For study participants with baseline eGFR less than 60mL/min/1.73 m2, the starting dose will be 10mg/day of finerenone (equivalent to 10mg/day in the placebo group), followed by 20 mg/day (equivalent to 20mg/day in the placebo group) approximately 4 weeks after the first dose, in accordance with the latest package insert. The dose should be increased to 20mg/day (equivalent to 20mg/day in the placebo group) in principle after 4 weeks from the start of the first dose, in accordance with the latest package insert. Study participants with a baseline eGFR of 60 mL/min/1.73m2 or higher will receive 20mg/day of finerenone (equivalent to 20mg/day in the placebo group) as the starting dose.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Study participants will be instructed to take either finerenone or placebo orally once daily (preferably at approximately the same time every during the morning). For study participants with baseline eGFR less than 60mL/min/1.73 m2, the starting dose will be 10mg/day of finerenone (equivalent to 10mg/day in the placebo group), followed by 20 mg/day (equivalent to 20mg/day in the placebo group) approximately 4 weeks after the first dose, in accordance with the latest package insert. The dose should be increased to 20mg/day (equivalent to 20mg/day in the placebo group) in principle after 4 weeks from the start of the first dose, in accordance with the latest package insert. Study participants with a baseline eGFR of 60 mL/min/1.73m2 or higher will receive 20mg/day of finerenone (equivalent to 20mg/day in the placebo group) as the starting dose.
Primary Outcome Measure Information:
Title
Change in CAVI
Description
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in UACR
Description
Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint)
Time Frame
12 weeks, 24 weeks
Title
Change in pentosidine
Description
Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary type IV collagen
Description
Proportional changes in geometric mean of urinary type IV collagen at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary alpha1-MG
Description
Proportional changes in geometric mean of urinary alpha1-MG at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary beta2-MG
Description
Proportional changes in geometric mean of urinary beta2-MG at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary NGAL
Description
Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary NAG
Description
Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks
Title
Change in urinary L-FABP
Description
Proportional changes in geometric mean of urinary L-FABP at 24 weeks post-protocol treatment compared to baseline
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koichi Node, MD, PhD
Phone
+81-952-34-2364
Email
node@cc.saga-u.ac.jp
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Koichi Node, MD, PhD
Organizational Affiliation
Saga University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atsushi Tanaka, MD, PhD
Phone
+81-952-34-2364
Email
tanakaa2@cc.saga-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)

We'll reach out to this number within 24 hrs