Cardiovascular Autonomic NeuropathyPhase 2FibroCANNCT06906081
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
A Phase 2 study testing Kerendia (Finerenone, BAY94-8862) in people with Cardiovascular Autonomic Neuropathy and Type 2 Diabetes, run by Peter Rossing at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cardiovascular Autonomic Neuropathy, Type 2 Diabetes, Diabetic Neuropathies
- What is being tested?
- Kerendia (Finerenone, BAY94-8862)
- 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
- 2 sitesDenmark
- Study dates
- 2 May 2025to Jan 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
To be included in this study the participants must fulfill the following inclusion criteria.
- Given informed consent
- Type 2 diabetes defined by WHO criteria
- Aged 40 ≥ at inclusion
- Pathological E/I ratio (Mean value of three measures)
Exclusion criteria Participants will be excluded in one or more of the following criteria are met.
- 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
- Hyperkalemia at screening visit (plasma potassium >4.8 mmol/l)
- eGFR < 25 ml/min/1.73m2
- Potassium plasma > 4.8 mmol/l (at randomization)
- Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
- Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit
- Have received chemotherapeutic treatment within last 12 months
- Grapefruit consumption that cannot be discontinued during the study period
- Inability to complete study protocol, assessed to investigator
- Not able to read, write and/or understand Danish
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Steno Diabetes Center Northern Denmark
Gistrup, 9260
Asbjørn Mohr Drewes, MD, professor, 99321111 ext. +45, amd@rn.dk
Christina Brock, professor, 99326240 ext. +45, christina.brock@rn.dk
- Not yet recruiting
Steno Diabetes Center Copenhagen
Herlev, 2730
Peter Rossing, Professor, MD, +4530913383, peter.rossing@regionh.dk
Christian Stevns Hansen, PhD, MD, +4561671618, christian.stevns.hansen@regionh.dk
About this study
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.
- Being tested
- Kerendia (Finerenone, BAY94-8862), Placebo
- Keywords
- Mineralocorticoid receptor antagonist (MRA), Cardiovascular autonomic neuropathy, Type 2 Diabetes, Diabetic Neuropathy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kerendia (Finerenone, BAY94-8862)Drug
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.
PlaceboDrug
Placebo tablets matching BAY94-8862 are administered orally.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Finerenone (active) | Experimental | Not described Receives: Drug: Kerendia (Finerenone, BAY94-8862) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio
Measured by vagus device
Measured: 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
R/S ratio (CART). Measured by Vagus device.
Measured: 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.
Valsalva manoeuvre (CART). Measured by Vagus device.
Measured: 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
Measured by vagus device as SDNN (Standard Deviation of Normal-to-Normal interbeat) intervals and RMSSD (Root Mean Square of Successive Differences between normal heartbeats). SDNN and RMSSD is measured in milliseconds.
Measured: 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.
Measured by vagus device as low and high frequency power in the unit milliseconds squared.
Measured: 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
Serum PRO-C6 and PRO-C3 assessed by ELISA.
Measured: 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 fibrosis markers in skin biopsies by PRO-C6
Pro-C6 by immunostaining
Measured: From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78
Between-group (finerenone vs. placebo) differences in changes on fibrosis markers in skin biopsies by C3M
C3M by immunostaining
Measured: From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start2 May 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (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 Cardiovascular Autonomic NeuropathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Rossing
- Sponsor type
- University, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, Aarhus University Hospital
- Responsible party
- Sponsor-investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Peter Rossing, Professor, MD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06906081
- Sponsor's protocol ID
- 2024-516597-30-00
- Other IDs
- 2024-516597-30-00
- Acronym
- FibroCAN
- Status last verified
- May 2025
- First submitted
- 3 Feb 2025
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 41130701
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
- ClinicalTrials.gov ID
- NCT06906081
- Acronym / sponsor ID
- FibroCAN / 2024-516597-30-00
- Keywords
- Mineralocorticoid receptor antagonist (MRA), Cardiovascular autonomic neuropathy, Type 2 Diabetes, Diabetic Neuropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peter RossingUniversity, hospital or other
- Collaborators
- Steno Diabetes Center Nordjylland, Aarhus University Hospital
- Study start
- 2 May 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 2 Apr 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Finerenone (active) | Experimental | Drug: Kerendia (Finerenone, BAY94-8862) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Kerendia (Finerenone, BAY94-8862)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. | Drug | Finerenone (active) |
| PlaceboPlacebo tablets matching BAY94-8862 are administered orally. | Drug | Placebo |
Primary outcome
Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio
Time frame: 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
Measured by vagus device
7 secondary outcomes
Between-group (finerenone vs. placebo) difference in changes on the CART R/S ratio
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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 fibrosis markers in skin biopsies by PRO-C6
Time frame: From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78
Between-group (finerenone vs. placebo) differences in changes on fibrosis markers in skin biopsies by C3M
Time frame: From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Derived from this study: PubMed 41130701Bitsch 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.
- Individual participant dataSharing planned: Yes
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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.
Peter Rossing, Professor, MD principal investigator
Steno Diabetes Center Copenhagen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Kerendia (Finerenone, BAY94-8862) in people with Cardiovascular Autonomic Neuropathy and Type 2 Diabetes, run by Peter Rossing at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Rossing, Professor, MD (+4530913383, peter.rossing@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio (time frame: 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). 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 NCT06906081, 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 25 May 2025.