NCT06906081|RecruitingPhase 2
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
FibroCAN
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FibroCAN
Sponsor study identifier
Secondary identifiers
CTIS
interventional
100
1 country
2
Study Start
May 2, 2025
Actual (reported)Primary Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diabetic neuropathy is a serious and common complication of diabetes that currently has no cure. One form of this condition is cardiovascular autonomic neuropathy (CAN), which affects about 20% of people with diabetes-an estimated 100 million people worldwide. CAN is a significant risk factor for death and health problems like heart disease and kidney damage, and may contribute to the high rates of cardiovascular-related deaths in people with diabetes. This study is a double-blind, randomized, placebo-controlled, two-center trial. The study aims to test whether finerenone can treat cardiovascular autonomic neuropathy in patients with type 2 diabetes. The trial will evaluate the effects of 78 weeks of treatment with finerenone or a placebo, assigned randomly in a 1:1 ratio, on early-stage cardiovascular autonomic neuropathy. The trial will include 100 participants with type 2 diabetes. Additionally, the study will investigate how the treatment impacts other types of neuropathy and related pathological mechanisms.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2025
Actual (reported)April 2, 2025
Actual (reported)May 2, 2025
Actual (reported)January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio
Measured by vagus device
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Between-group (finerenone vs. placebo) difference in changes on the CART R/S ratio
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Between-group (finerenone vs. placebo) difference in changes on the CART Valsalva manoeuvre.
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Titration of finerenone will be based on baseline eGFR. Participants with eGFR \> 60 mL/min/1.73m² will start on a 20mg dosage. Medication dosage will be increased to 40 mg after one month if serum potassium \< 4.8 mmol/l. If side effects occur at any dosage, the dosage will be reduced to the previous level. Participants with eGFR \< 60 and \>25 Participants with eGFR \< 60 mL/min/1.73m² (and eGFR \< 25 mL/min/1.73m²) will start on a 10mg dosage. Medication dosage will be increased to 20 mg after one month if serum potassium \< 4.8 mmol/l. Subsequently, Medication dosage will be increased to 40 mg after an additional one month if serum potassium \< 4.8 mmol/l. If side effects occur at any dosage, the dosage will be reduced to the previous level. Finerenone is administered orally as immediate release tablets.
Steno Diabetes Center Northern Denmark
Gistrup, 9260, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Bitsch Poulsen M, Okdahl T, Buciek JH, Drewes AM, Karlsson P, Ahluwalia TS, Brock B, Brock C, Rossing P, Hansen CS. Protocol for the FibroCAN study: a randomised controlled trial of finerenone treatment for early-stage cardiovascular autonomic neuropathy in type 2 diabetes. BMJ Open. 2025 Oct 23;15(10):e101074. doi: 10.1136/bmjopen-2025-101074.
Peter Rossing, Professor, MD
Steno Diabetes Center Copenhagen
First Submitted
February 3, 2025
First Posted
April 2, 2025
Study Start
May 2, 2025
Actual (reported)Primary Completion
January 2028
EstimatedBetween-group (finerenone vs. placebo) differences in changes on heart rate variability (HRV) by SDNN and RMSSD
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Between-group (finerenone vs. placebo) differences in changes on heart rate variability (HRV) by high and low frequency power.
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Between-group (finerenone vs. placebo) differences in changes on fibrosis markers in serum
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78. Skin biopsies on week 0, week 36 and week 78.
Between-group (finerenone vs. placebo) differences in changes on inflammation markers
From baseline to the end of treatment at 78 weeks. Tested at screening, week 0, week 12, week 24, week 36, week 52 and week 78
Between-group (finerenone vs. placebo) differences in changes on markers of retinopathy
From enrollement to the end of treatment at 78 weeks. Tested at week 0, week 36 and week 78.
Between-group (finerenone vs. placebo) differences in changes on markers of corneal neuropathy by CNFD
From enrollement to the end of treatment at 78 weeks. Tested at week 0, week 36 and week 78.
Placebo tablets matching BAY94-8862 are administered orally.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 25, 2025
Record last verified: 2025-05
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Source: ClinicalTrials.gov.
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