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The FibroCAN study
EU CTIS ID: 2024-516597-30-00
What this study is testing
The objective of this study is to investigate the disease modifying effect of finerenone on early CAN in a 78-week doubled blinded, randomized placebo-controlled multi-centre trial of people with type 2 diabetes and early-stage CAN. Treatment effects on neuropathy measures, levels of fibrosis and inflammation and heart function will be explored.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Given informed consent
- Type 1 diabetes or type 2 diabetes defined by WHO criteria
- Aged 40 to 79 years at inclusion
- Pathological E/I ratio (Mean value of three measures) or a pathological E/I ratio and another pathological CART
You likely can't join if
- No CAN (no abnormal CARTs)
- Server 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).
- Not able to read, write and/or understand Danish
- Breastfeeding
See the full eligibility criteria
- Given informed consent
- Type 1 diabetes or type 2 diabetes defined by WHO criteria
- Aged 40 to 79 years at inclusion
- Pathological E/I ratio (Mean value of three measures) or a pathological E/I ratio and another pathological CART
- No CAN (no abnormal CARTs)
- Server 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).
- Not able to read, write and/or understand Danish
- Breastfeeding
- Nephropathy requiring dialysis
- Beta-block treatment not paused ≥24 hours prior to cardiovascular reflex testing, or if pausing treatment was not deemed safe by the investigator
- Hyperkalemia at sceening visit (plasma potassium >4.8 mmol/l)
- eGFR < 25 ml/min/1.73m2
- Plasma potassium > 4.8 mmol/l (at randomization)
- have received chemotherapeutic treatment within last 12 months
- Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Grapefruit consumption that cannot be discontinued during the study period
- 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
- Severe hepatic impairment
- inability to complete study protocol, assessed to investigator
- Three pathological CARTs
- HbA1C >100 mmol/mol
- 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
The study team makes the final eligibility decision.
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.