BridgeMD
Effect of Treatment with Finerenone on Cardio-Renal Target Organ Damage in Patients with Type 2 Diabetes – A Randomized Trial
EU CTIS ID: 2023-504446-58-00
What this study is testing
To examine the effect of combination therapy with finerenone and sodium-glucose cotransporter-2 (SGLT2) inhibitors. Our hypothesis is that the combination therapy will be either synergetic or additive on various cardio-renal endpoints.
- Therapeutic use (Phase IV)
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
- Diagnosis of type 2 diabetes according to the World Health Organization definition
- Chronic kidney disease defined as eGFR ≥ 25 ml/min/1.73 m2 and elevated albuminuria (urinary albumin-to-creatine ratio of 30-5000 mg/g).
- Current treatment with an sodium-glucose-cotransporter 2 (SGLT2)-inhibitor at maximally tolerated dose
- Current treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) at maximally tolerated dose
- Serum potassium level of 4.8 mmol/L or less at the time of screening
- Age above 18 years
You likely can't join if
- Inability to give informed consent
- Severe hepatic disease (serum ALAT above 3x upper limit of normal)
- Active cancer diagnosis other than basal cell carcinoma
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
See the full eligibility criteria
- Diagnosis of type 2 diabetes according to the World Health Organization definition
- Chronic kidney disease defined as eGFR ≥ 25 ml/min/1.73 m2 and elevated albuminuria (urinary albumin-to-creatine ratio of 30-5000 mg/g).
- Current treatment with an sodium-glucose-cotransporter 2 (SGLT2)-inhibitor at maximally tolerated dose
- Current treatment with an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin receptor blocker (ARB) at maximally tolerated dose
- Serum potassium level of 4.8 mmol/L or less at the time of screening
- Age above 18 years
- Speak and understand Danish fluently
- Inability to give informed consent
- Severe hepatic disease (serum ALAT above 3x upper limit of normal)
- Active cancer diagnosis other than basal cell carcinoma
- Treatment with systemic steroids at time of randomization.
- Bariatric surgery within 2 years or other gastrointestinal surgeries that induce chronic malabsorption.
- Alcohol or drug abuse within 3 months of informed consent that would interfere with trial participation or any ongoing condition leading to decreased compliance with study procedures or study drug intake.
- Chronic or acute pancreatitis.
- Pregnancy or breastfeeding
- Previous renal or heart transplantation
- Poorly controlled medical condition, e.g. congestive heart failure (New York Heart Association III-IV or EF ≤ 40%), recent (within 3 months) stroke or acute myocardial infarction or any other condition that in the opinion of the investigator will put the trial participant at risk if participating in the trial.
- Allergy to finerenone or any of the excipients contained in the drug.
- Current systemic treatment with strong inhibitors of CYP3A4 (e.g. itraconazol, ketocona-zole, ritonavir, cobicistat, clarithromycin) or strong inducers of CYP3A4 (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital).
- Current treatment with other mineralocorticoid receptor antagonists (e.g. spironolactone, eplerenone etc.).
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- Addison’s disease.
- Contraindications to magnetic resonance imaging (MRI).
- Severe renal disease with eGFR<25 ml/min/1.73m2
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, 18-64 years, 65+ 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.