Type 2 DiabetesPhase 4FIVE-STARNCT05887817
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
A Phase 4 study testing Finerenone in people with Type 2 Diabetes and Chronic Kidney Diseases, run by Saga University at 1 site in Japan.
Trial summary
To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes, Chronic Kidney Diseases
- What is being tested?
- Finerenone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 7 Sep 2023to 31 Jul 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 16Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR)
To evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in patients with type 2 diabetes and chronic kidney disease.
Read the 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.
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Being tested
- Finerenone, Placebo
- Keywords
- Finerenone, Vascular Stiffness, Biomarker
- Medical subject headings
- Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FinerenoneDrug
Also called Kerendia
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Finerenone | Experimental | Kerendia® tablets Receives: Drug: Finerenone |
| Placebo | Placebo comparator | Placebo tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CAVI
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
Measured: 24 weeks
Secondary outcomes (8)
Change in UACR
Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint)
Measured: 12 weeks, 24 weeks
Change in pentosidine
Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
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
Measured: 24 weeks
Change in urinary alpha1-MG
Proportional changes in geometric mean of urinary alpha1-MG at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
Change in urinary beta2-MG
Proportional changes in geometric mean of urinary beta2-MG at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
Change in urinary NGAL
Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
Change in urinary NAG
Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
Change in urinary L-FABP
Proportional changes in geometric mean of urinary L-FABP at 24 weeks post-protocol treatment compared to baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start7 Sep 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saga University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koichi Node, Saga University
- Investigators
- Koichi Node, MD, PhD, Principal investigator, Saga University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887817
- Sponsor's protocol ID
- 00002
- Acronym
- FIVE-STAR
- Status last verified
- Feb 2024
- First submitted
- 24 May 2023
- Last updated
- 7 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tanaka A, Shibata H, Imai T, Yoshida H, Miyazono M, Takahashi N, Fukuda D, Okada Y, Teragawa H, Suwa S, Kida K, Moroi M, Taguchi I, Toyoda S, Shimabukuro M, Tanabe K, Tanaka K, Nangaku M, Node K; FIVE-STAR trial investigators. Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR). Cardiovasc Diabetol. 2023 Jul 31;22(1):194. doi: 10.1186/s12933-023-01928-y.
PubMed 37525257
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in Type 2 Diabetes and Chronic Kidney Disease (FIVE-STAR)
- ClinicalTrials.gov ID
- NCT05887817
- Acronym / sponsor ID
- FIVE-STAR / 00002
- Conditions
- Type 2 Diabetes, Chronic Kidney Diseases
- Keywords
- Finerenone, Vascular Stiffness, Biomarker
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Saga UniversityUniversity, hospital or other
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| Finerenone | Experimental | Drug: FinerenoneKerendia® tablets |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo tablets |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FinerenoneAlso: KerendiaStudy 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. | Drug | Finerenone |
| PlaceboStudy 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. | Drug | Placebo |
Primary outcome
Change in CAVI
Time frame: 24 weeks
Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline
8 secondary outcomes
Change in UACR
Time frame: 12 weeks, 24 weeks
Change in pentosidine
Time frame: 24 weeks
Change in urinary type IV collagen
Time frame: 24 weeks
Change in urinary alpha1-MG
Time frame: 24 weeks
Change in urinary beta2-MG
Time frame: 24 weeks
Change in urinary NGAL
Time frame: 24 weeks
Change in urinary NAG
Time frame: 24 weeks
Change in urinary L-FABP
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 37525257Tanaka A, Shibata H, Imai T, Yoshida H, Miyazono M, Takahashi N, Fukuda D, Okada Y, Teragawa H, Suwa S, Kida K, Moroi M, Taguchi I, Toyoda S, Shimabukuro M, Tanabe K, Tanaka K, Nangaku M, Node K; FIVE-STAR trial investigators. Rationale and design of an investigator-initiated, multicenter, prospective, placebo-controlled, double-blind, randomized trial to evaluate the effects of finerenone on vascular stiffness and cardiorenal biomarkers in type 2 diabetes and chronic kidney disease (FIVE-STAR). Cardiovasc Diabetol. 2023 Jul 31;22(1):194. doi: 10.1186/s12933-023-01928-y.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Koichi Node, MD, PhD principal investigator
Saga University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Finerenone in people with Type 2 Diabetes and Chronic Kidney Diseases, run by Saga University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CAVI (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05887817, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.