NCT06906081RecruitingPhase 2
Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
Source: ClinicalTrials.gov · Last updated 25 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 2 May 2025
- Primary completion date
- Jan 2028
- Lead sponsor
- Peter Rossing
- Diseases
- Type 2 diabetes
- NCT number
- NCT06906081
- EU CT number
- 2024-516597-30-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 2 May 2025 to the primary completion date, Jan 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Congestive heart failure (NYHA class 3-4)
- History of cardiac arrhythmia
- Severe forms of respiratory disease including asthma and COPD
- Severe hepatic impairment
Lab values
- 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.
- Hyperkalemia at screening visit (plasma potassium \>4.8 mmol/l)
- eGFR \< 25 ml/min/1.73m2
- Potassium plasma \> 4.8 mmol/l (at randomization)
Other
- No CAN (no abnormal CARTs)
- Definite CAN (more than one abnormal CART)
- Atrial fibrillation/flutter
- 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).
- Lactose intolerance
- Breastfeeding
- Nephropathy requiring dialysis
- Beta-blocker-use
- 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
Criteria the registry did not label
- 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)
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Steno Diabetes Center Northern Denmark Coordinator of this site? Confirm its status | Gistrup | Denmark | Recruiting |
| Steno Diabetes Center Copenhagen Coordinator of this site? Confirm its status | Herlev | Denmark | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.