NCT06906081

Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peter Rossing · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	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	Placebo	Placebo tablets matching BAY94-8862 are administered orally.

Timeline

• Start date: 2025-05-02
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2025-04-02
• Last updated: 2025-05-25

Locations

2 sites across 1 country: Denmark