Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

PHASE2RecruitingINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

May 2, 2025

Primary Completion Date

January 31, 2028

Study Completion Date

January 31, 2028

Conditions
Cardiovascular Autonomic NeuropathyType 2 DiabetesDiabetic 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.

Trial Locations (2)

2730

NOT_YET_RECRUITING

Steno Diabetes Center Copenhagen, Herlev

9260

RECRUITING

Steno Diabetes Center Northern Denmark, Gistrup

All Listed Sponsors
collaborator

Steno Diabetes Center Nordjylland

OTHER

collaborator

Aarhus University Hospital

OTHER

lead

Peter Rossing

OTHER