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New treatment option for Cardiovascular Autonomic Neuropathy
Official title Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
ClinicalTrials.gov ID: NCT06906081
What this study is testing
What is Kerendia (Finerenone, BAY94-8862)?
Kerendia (Finerenone, BAY94-8862) is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for cardiovascular autonomic neuropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join if
- To be included in this study the participants must fulfill the following .
- Given informed consent
- Type 2 diabetes defined by WHO criteria
- Aged 40 ≥ at inclusion
- Pathological E/I ratio (Mean value of three measures)
You likely can't join if
- 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...
- Atrial fibrillation/flutter
See the full eligibility criteria
- To be included in this study the participants must fulfill the following .
- Given informed consent
- Type 2 diabetes defined by WHO criteria
- Aged 40 ≥ at inclusion
- Pathological E/I ratio (Mean value of three measures)
- 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...
- 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 people of childbearing potential (WOCBP) must have a negative result of a highly sensitive urine HCG (pregnancy test) performed at screening. people of childbearing potential must agree to use a highly...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Gistrup, Denmark
- Herlev, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gistrup, Denmark; Herlev, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.