Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
FibroCAN
1 other identifier
interventional
100
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedStudy Start
First participant enrolled
May 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
May 25, 2025
May 1, 2025
2.7 years
February 3, 2025
May 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (7)
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
Between-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.
- +2 more secondary outcomes
Other Outcomes (21)
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.
- +18 more other outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORFinerenone (active)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Given informed consent
- Type 2 diabetes defined by WHO criteria
- Pathological E/I ratio (Mean value of three measures)
You may not qualify if:
- No CAN (no abnormal CARTs)
- Definite CAN (more than one abnormal CART)
- HbA1C \>100 mmol/L
- Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.
- Atrial fibrillation/flutter
- Congestive heart failure (NYHA class 3-4)
- History of cardiac arrhythmia
- Severe forms of respiratory disease including asthma and COPD
- Any nondiabetic cause of neuropathy
- All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).
- Severe hepatic impairment
- Lactose intolerance
- Breastfeeding
- Nephropathy requiring dialysis
- Beta-blocker-use
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter Rossinglead
- Steno Diabetes Center Nordjyllandcollaborator
- Aarhus University Hospitalcollaborator
Study Sites (2)
Steno Diabetes Center Northern Denmark
Gistrup, 9260, Denmark
Steno Diabetes Center Copenhagen
Herlev, 2730, Denmark
Related Publications (1)
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.
PMID: 41130701DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rossing, Professor, MD
Steno Diabetes Center Copenhagen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, professor
Study Record Dates
First Submitted
February 3, 2025
First Posted
April 2, 2025
Study Start
May 2, 2025
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
January 1, 2028
Last Updated
May 25, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF