Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Phase 2

Recruiting

• Conditions: Cardiovascular Autonomic Neuropathy; Type 2 Diabetes; Diabetic Neuropathies
• Interventions: Drug: Placebo; Drug: Kerendia (Finerenone, BAY94-8862)

• Registration Number: NCT06906081
• Lead Sponsor: Peter Rossing

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-03-25
• Study First Posted: 2025-04-02
• Status Verified: 2025-05
• Study Start: 2025-05-02
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-25
• Primary Completion: 2028-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Finerenone (active)	Kerendia (Finerenone, BAY94-8862)	-

Primary Outcome Measures

Name	Time	Method
Between-group (finerenone vs. placebo) difference in changes on the CART E/I 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	Measured by vagus device

Secondary Outcome Measures

Name	Time	Method
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	R/S ratio (CART). Measured by Vagus device.
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	Valsalva manoeuvre (CART). Measured by Vagus device.
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	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.
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	Measured by vagus device as low and high frequency power in the unit milliseconds squared.
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.	Serum PRO-C6 and PRO-C3 assessed by ELISA.
Between-group (finerenone vs. placebo) differences in changes on fibrosis markers in skin biopsies by PRO-C6	From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78	Pro-C6 by immunostaining
Between-group (finerenone vs. placebo) differences in changes on fibrosis markers in skin biopsies by C3M	From baseline to the end of treatment at 78 weeks. Tested at week 0, 36 and 78	C3M by immunostaining

Trial Locations

Locations (2)

Steno Diabetes Center Northern Denmark; 🇩🇰 Gistrup, Denmark

Steno Diabetes Center Copenhagen; 🇩🇰 Herlev, Denmark