Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Sponsor
Peter Rossing
Study ID
NCT06906081
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Kerendia (Finerenone, BAY94-8862) — 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.
  • Placebo — DRUG
    Placebo tablets matching BAY94-8862 are administered orally.

Study Details

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.

Key Dates

Start date
May 2, 2025
Status verified
May 2025
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
  • Experimental: Finerenone (active)

Primary Outcome Measure

Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio [ Time Frame: 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 ]

Central Contacts

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