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

NCT05887817 | Active Not Recruiting Phase 4

• 1 other identifier: 00002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 2 Diabetes; Chronic Kidney Diseases

Keywords

Finerenone; Vascular Stiffness; Biomarker

Outcome Measures

Primary Outcomes (1)

• Change in CAVI

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

  24 weeks

Secondary Outcomes (8)

• Change in UACR

  12 weeks, 24 weeks

• Change in pentosidine

  24 weeks

• Change in urinary type IV collagen

  24 weeks

• Change in urinary alpha1-MG

  24 weeks

• Change in urinary beta2-MG

  24 weeks

Study Arms (2)

Finerenone

EXPERIMENTAL

Kerendia® tablets

Drug: Finerenone

Placebo

PLACEBO COMPARATOR

Placebo tablets

Drug: Placebo

Interventions

Finerenone DRUG

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.

Also known as: Kerendia

Finerenone

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saga University: lead

Study Sites (1)

Saga University Hospital

Saga, 849-8501, Japan

Location

Related Publications (1)

• 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.

  PMID: 37525257 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Interventions

finerenone

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Koichi Node, MD, PhD

  Saga University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Assignment

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: September 7, 2023
• Primary Completion: February 28, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 7, 2024

Record last verified: 2024-02

Locations

JP (1)