NCT06906081 Finerenone Treatment for Diabetic Cardiovascular Autonomic Neuropathy: the FibroCAN Study
| NCT ID | NCT06906081 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peter Rossing |
| Condition | Cardiovascular Autonomic Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-05-02 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-05-02 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Peter Rossing, Professor, MD
PRINCIPAL INVESTIGATOR
Steno Diabetes Center Copenhagen
Frequently Asked Questions
Who can join the NCT06906081 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Cardiovascular Autonomic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06906081 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06906081 currently recruiting?
Yes, NCT06906081 is actively recruiting participants. Contact the research team at peter.rossing@regionh.dk for enrollment information.
Where is the NCT06906081 trial being conducted?
This trial is being conducted at Gistrup, Denmark, Herlev, Denmark.
Who is sponsoring the NCT06906081 clinical trial?
NCT06906081 is sponsored by Peter Rossing. The principal investigator is Peter Rossing, Professor, MD at Steno Diabetes Center Copenhagen. The trial plans to enroll 100 participants.