Actively Recruiting

Phase 2
Age: 40Years +
All Genders
ID06906081

Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Led by Peter Rossing · Updated on 2025-05-25

100

Participants Needed

2

Research Sites

N/A

Total Duration

On this page

Sponsors

P

Peter Rossing

Lead Sponsor

S

Steno Diabetes Center Nordjylland

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the potential of finerenone to treat cardiovascular autonomic neuropathy (CAN), a serious complication affecting about 20% of people with type 2 diabetes. CAN increases the risk of heart disease, kidney damage, and death, and this phase 2, double-blind, randomized, placebo-controlled trial aims to better understand if finerenone can improve early-stage CAN and other neuropathies in patients with type 2 diabetes. Participants will receive either finerenone or a placebo for 78 weeks. The finerenone dosage will be adjusted based on kidney function and potassium levels, starting at 10mg, 20mg, or 40mg daily as tablets taken by mouth. Those with better kidney function start higher and may increase dose if potassium levels allow. The study will compare changes between the finerenone group and the placebo group over this treatment period. During the trial, participants will attend visits at screening, baseline, and at weeks 12, 24, 36, 52, and 78. Tests will measure heart rate variability, responses to cardiovascular autonomic reflex tests, and fibrosis markers in blood and skin biopsies. Researchers will monitor safety, medication adherence, and neuropathy progression. The study will last about 78 weeks per participant, with ongoing assessments to evaluate finerenone's effects on CAN and related conditions.

CONDITIONS

Brief Title

Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Who Can Participate

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Given informed consent
  • Diagnosed with type 2 diabetes based on WHO criteria
  • Aged 40 years or older at inclusion
  • Have a pathological E/I ratio based on cardiovascular autonomic reflex testing (mean of three measures)
Not Eligible

You will not qualify if you...

  • No cardiovascular autonomic neuropathy (normal CARTs)
  • Definite cardiovascular autonomic neuropathy with more than one abnormal CART
  • HbA1C greater than 100 mmol/L
  • Use of potassium-sparing diuretics or mineralocorticoid receptor antagonists that cannot be stopped 4 weeks before screening
  • Atrial fibrillation or flutter
  • Congestive heart failure classified as NYHA class 3 or 4
  • History of cardiac arrhythmia
  • Severe respiratory diseases including asthma and COPD
  • Neuropathy from causes other than diabetes
  • Women of childbearing potential without a negative pregnancy test or not using effective contraception
  • Severe liver impairment
  • Lactose intolerance
  • Breastfeeding
  • Kidney failure requiring dialysis
  • Use of beta-blockers
  • Hyperkalemia at screening (plasma potassium over 4.8 mmol/L)
  • Estimated glomerular filtration rate (eGFR) below 25 ml/min/1.73m2
  • Treatment with strong CYP3A4 inhibitors or inducers that cannot be stopped 4 weeks before screening
  • Chemotherapy within the last 12 months
  • Inability to follow the study protocol or understand Danish
  • Regular grapefruit consumption that cannot be stopped during the study period
  • Other medical or logistical reasons assessed by the investigator preventing participation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 78 weeks

Participants receive either finerenone or placebo tablets orally, with dosage adjustments based on kidney function and potassium levels, over the course of the treatment period.

Visits at week 0, 12, 24, 36, 52, and 78

Trial Site Locations

Total: 2 locations

1

Steno Diabetes Center Northern Denmark

Gistrup, Denmark, 9260

Actively Recruiting

2

Steno Diabetes Center Copenhagen

Herlev, Denmark, 2730

Not Yet Recruiting

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Research Team

P

Peter Rossing, Professor, MD

C

Christian Stevns Hansen, Ph.D, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Protocol for the FibroCAN study: a randomised controlled trial of finerenone treatment for early-stage cardiovascular autonomic neuropathy in type 2 diabetes.

Maria Bitsch Poulsen, Tina Okdahl, Jens Hove Buciek...

https://pubmed.ncbi.nlm.nih.gov/41130701