Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

NCT ID: NCT06906081

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2028-01-31

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.

Conditions

Cardiovascular Autonomic Neuropathy; Type 2 Diabetes; Diabetic Neuropathies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablets matching BAY94-8862 are administered orally.

Finerenone (active)

Group Type: EXPERIMENTAL

Kerendia (Finerenone, BAY94-8862)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Placebo

Placebo tablets matching BAY94-8862 are administered orally.

Intervention Type: DRUG

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Steno Diabetes Center Nordjylland

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: collaborator

Peter Rossing

OTHER

Sponsor Role: lead

Responsible Party

Peter Rossing

MD, professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Peter Rossing, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Steno Diabetes Center Northern Denmark

Gistrup, , Denmark

Site Status: RECRUITING

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status: NOT_YET_RECRUITING

Countries

Denmark

Central Contacts

Peter Rossing, Professor, MD

Role: CONTACT

peter.rossing@regionh.dk

+4530913383

Christian Stevns Hansen, Ph.D, MD

Role: CONTACT

christian.stevns.hansen@regionh.dk

+4561671618

Facility Contacts

Asbjørn Mohr Drewes, MD, professor

Role: primary

amd@rn.dk

99321111 ext. +45

Christina Brock, professor

Role: backup

christina.brock@rn.dk

99326240 ext. +45

Peter Rossing, Professor, MD

Role: primary

peter.rossing@regionh.dk

+4530913383

Christian Stevns Hansen, PhD, MD

Role: backup

christian.stevns.hansen@regionh.dk

+4561671618

References

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.

Reference Type: DERIVED

PMID: 41130701 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2024-516597-30-00

Identifier Type: CTIS

Identifier Source: secondary_id

2024-516597-30-00

Identifier Type: -

Identifier Source: org_study_id