Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study

Peter Rossing

Status and phase

Enrolling

Phase 2

Conditions

Cardiovascular Autonomic Neuropathy

Diabetic Neuropathies

Type 2 Diabetes

Treatments

Drug: Placebo

Drug: Kerendia (Finerenone, BAY94-8862)

Study type

Interventional

Funder types

Other

Identifiers

NCT06906081

2024-516597-30-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

To be included in this study the participants must fulfill the following inclusion criteria.

Given informed consent
Type 2 diabetes defined by WHO criteria
Aged 40 ≥ at inclusion
Pathological E/I ratio (Mean value of three measures)

Exclusion criteria Participants will be excluded in one or more of the following criteria are met.

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.
Atrial fibrillation/flutter
Congestive heart failure (NYHA class 3-4)
History of cardiac arrhythmia
Severe forms of respiratory disease including asthma and COPD
Any nondiabetic cause of neuropathy
All female subjects of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. Subjects of childbearing potential must agree to use a highly effective form of contraception throughout the duration of the study (list of definition on WOCBP and accepted contraception in appendix A).
Severe hepatic impairment
Lactose intolerance
Breastfeeding
Nephropathy requiring dialysis
Beta-blocker-use
Hyperkalemia at screening visit (plasma potassium >4.8 mmol/l)
eGFR < 25 ml/min/1.73m2
Potassium plasma > 4.8 mmol/l (at randomization)
Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
Treament with moderate to strong CYP3A4-induceres (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital, St John's Wort or efavirenz) which cannot be discontinued 4 weeks prior to screening visit
Have received chemotherapeutic treatment within last 12 months
Grapefruit consumption that cannot be discontinued during the study period
Inability to complete study protocol, assessed to investigator
Not able to read, write and/or understand Danish