Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorPeter Rossing
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Given informed consent
Type 2 diabetes defined by WHO criteria
Aged 40 ≥ at inclusion
Pathological E/I ratio (Mean value of three measures)
Disqualifiers
No CAN (no abnormal CARTs)
Definite CAN (more than one abnormal CART)
HbA1C >100 mmol/L
Treatment with potassium-sparing diuretics (amiloride) or MRAs e.g., spironolactone or eplerenone which cannot be discontinued 4 weeks prior to screening visit. The patient's primary physician, who is not involved in this study, will determine if discontinuation is possible.
Trial design
Design model
Parallel
Treatments tested in this trial
Kerendia (Finerenone, BAY94-8862)
DrugTitration 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
DrugPlacebo tablets matching BAY94-8862 are administered orally.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: Finerenone (active)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Between-group (finerenone vs. placebo) difference in changes on the CART E/I ratio
Measured by vagus device
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 78Secondary outcomes
1
Between-group (finerenone vs. placebo) difference in changes on the CART R/S ratio
R/S ratio (CART). Measured by Vagus device.
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 782
Between-group (finerenone vs. placebo) difference in changes on the CART Valsalva manoeuvre.
Valsalva manoeuvre (CART). Measured by Vagus device.
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 783
Between-group (finerenone vs. placebo) differences in changes on heart rate variability (HRV) by SDNN and RMSSD
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.
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 784
Between-group (finerenone vs. placebo) differences in changes on heart rate variability (HRV) by high and low frequency power.
Measured by vagus device as low and high frequency power in the unit milliseconds squared.
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 78Other outcomes
1
Between-group (finerenone vs. placebo) differences in changes on inflammation markers
Olink inflammation markers will be measured with PCR.
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 782
Between-group (finerenone vs. placebo) differences in changes on markers of retinopathy
Markers of retinopathy (nonproliferativ/proliferative retinopathy and retinal nerve fibre layer thickness by optical coherence tomography)
Time frame
From enrollement to the end of treatment at 78 weeks. Tested at week 0, week 36 and week 78.3
Between-group (finerenone vs. placebo) differences in changes on markers of corneal neuropathy by CNFD
Overall to quantify the severity of small nerve fibre damage by confocal corneal microscopy. Quantified by corneal nerve fiber density (CNFD) measured in fibers per mm2.
Time frame
From enrollement to the end of treatment at 78 weeks. Tested at week 0, week 36 and week 78.4
Between-group (finerenone vs. placebo) differences in changes on markers of corneal by neuropathy by CNBD
Overall to quantify the severity of small nerve fibre damage by confocal corneal microscopy. Quantified including corneal nerve branch density (CNBD) measured in branches per mm2.
Time frame
From enrollement to the end of treatment at 78 weeks. Tested at week 0, week 36 and week 78.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Peter Rossing
Lead sponsor
Steno Diabetes Center Copenhagen
Sponsor institution
Steno Diabetes Center Nordjylland
Collaborator
Aarhus University Hospital
Collaborator
Source ClinicalTrials.gov