Logo 1 Logo 2

Clinical Trial Details

Trial ID: L0427
Source ID: NCT05887817
Associated Drug: Finerenone
Title: Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
Acronym: FIVE-STAR
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Chronic Kidney Diseases
Interventions: DRUG: Finerenone|DRUG: Placebo
Outcome Measures: Primary: Change in CAVI, Change in CAVI at 24 weeks after initiation of protocol treatment compared to baseline, 24 weeks | Secondary: Change in UACR, Proportional changes in geometric mean of UACR at 12 and 24 weeks post-protocol treatment compared to baseline (key secondary endpoint), 12 weeks, 24 weeks|Change in pentosidine, Proportional changes in geometric mean of pentosidine at 24 weeks post-protocol treatment compared to baseline, 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, 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, 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, 24 weeks|Change in urinary NGAL, Proportional changes in geometric mean of urinary NGAL at 24 weeks post-protocol treatment compared to baseline, 24 weeks|Change in urinary NAG, Proportional changes in geometric mean of urinary NAG at 24 weeks post-protocol treatment compared to baseline, 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, 24 weeks
Sponsor/Collaborators: Sponsor: Saga University
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 100
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-09-07
Completion Date: 2026-07-31
Results First Posted:
Last Update Posted: 2024-02-07
Locations: Saga University Hospital, Saga, 849-8501, Japan
URL: https://clinicaltrials.gov/show/NCT05887817