The FibroCAN study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

2 May 2025 → ongoing

Decision date (initial)

2024-11-20

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

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.

Conditions and MedDRA coding

Diabetic cardiovascular autonomic neuropathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Given informed consent
2. Type 1 diabetes or type 2 diabetes defined by WHO criteria
3. Aged 40 to 79 years at inclusion
4. Pathological E/I ratio (Mean value of three measures) or a pathological E/I ratio and another pathological CART

Exclusion criteria 24

1. No CAN (no abnormal CARTs)
2. have received chemotherapeutic treatment within last 12 months
3. inability to complete study protocol, assessed to investigator
4. Three pathological CARTs
5. HbA1C >100 mmol/mol
6. 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
7. Atrial fibrillation/flutter
8. Congestive heart failure (NYHA class 3-4)
9. History of cardiac arrhythmia
10. Server forms of respiratory disease including asthma and COPD
11. Any nondiabetic cause of neuropathy
12. 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).
13. Not able to read, write and/or understand Danish
14. Breastfeeding
15. Nephropathy requiring dialysis
16. Beta-block treatment not paused ≥24 hours prior to cardiovascular reflex testing, or if pausing treatment was not deemed safe by the investigator
17. Hyperkalemia at sceening visit (plasma potassium >4.8 mmol/l)
18. eGFR < 25 ml/min/1.73m2
19. Plasma potassium > 4.8 mmol/l (at randomization)
20. Treatment with strong CYP3A4-inhibitors (e.g. Itraconazol, ketoconazol, ritonavir, cobicistat, clarithromycin) which cannot be discontinued 4 weeks prior to screening visit
21. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
22. Grapefruit consumption that cannot be discontinued during the study period
23. 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
24. Severe hepatic impairment

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The CART E/I ratio (by the Vagustm device)

Secondary endpoints 4

1. Cardiovascular reflex tests: R/S ratio, Valsalva manoeuvre (CARTs)
2. HRV indices (SDNN, RMSSD, Low and high-frequency power) (by the Vagustm device)
3. Fibrosis markers (serum PRO-C6 and C3M assessed by ELISA)
4. Fibrosis markers in skin biopsies (Pro-C6 and C3M by immunostaining (Only week 0, 36, 78)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Peter Rossing

Third parties 8

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications