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Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

NCT06906081 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-05-25

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Steno Diabetes Center Nordjylland

    collaborator OTHER

  • Aarhus University Hospital

    collaborator OTHER

  • Peter Rossing

    lead OTHER

Principal Investigators

  • Peter Rossing, Professor, MD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06906081 on ClinicalTrials.gov