CKD study: Spironolactone
Official title Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects (COMPARE-VS)
ClinicalTrials.gov ID: NCT07304817
What this study is testing
What is vicadrostat / empagliflozin combination 1?
This is an investigational combination of two daily pills being studied for chronic kidney disease. Vicadrostat is designed to stop the body from making a hormone called aldosterone, while empagliflozin is designed to help the kidneys remove extra sugar and salt.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the two drug combos affect kidney function and blood/urine protein patterns differently.
- Who it's for
- Adults who have chronic kidney disease together with cardiovascular disease or heart failure.
- What's involved
- Participants will take study pills every day for about six months and have regular blood tests and check‑ups to monitor safety and kidney function.
- Time commitment
- The trial lasts 26 weeks with clinic visits and lab tests scheduled throughout the period.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Provided written and dated informed consent for participation prior to trial admission,
- Age ≥18 years, female or male
- Patients with
- Heart failure\ 1 (any LVEF) and eGFR\ 2 between 25-90 mL/min/1.73m2 OR
- Established cardiovascular disease\ 3 and eGFR between 25-60 mL/min/1.73m2 OR
You likely can't join if
- Inability to understand and sign informed consent
- Absolute contra-indication for aldosterone antagonist
- Absolute contra-indication for a SGLT2-inhibitor
- Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
See the full eligibility criteria
- Provided written and dated informed consent for participation prior to trial admission,
- Age ≥18 years, female or male
- Patients with
- Heart failure\ 1 (any LVEF) and eGFR\ 2 between 25-90 mL/min/1.73m2 OR
- Established cardiovascular disease\ 3 and eGFR between 25-60 mL/min/1.73m2 OR
- Established cardiovascular disease and type 2 diabetes and eGFR between 25-90 mL/min/1.73m2
- Serum potassium ≤ 5.0 mmol
- Currently treated or eligible for treatment with Empagliflozin\ 4
- Not using a MRA or AS inhibitor in the last 6 months prior to enrollment
- On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment
- Outpatient.
- 1 HF is defined as the definition used in the most recent ESC guidelines for HF.
- 2 eGFR as assessed by the 2009 CKD-EPI without the race coefficient
- 3 Cardiovascular disease is defined as a history of a myocardial infarction, coronary bypass surgery, PCI, or proven coronary artery disease (e.g. by coronary angiography, CT-scan, etc.)
- 4 If switching from another SGLT2i to Empagliflozin people can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8.
- Inability to understand and sign informed consent
- Absolute contra-indication for aldosterone antagonist
- Absolute contra-indication for a SGLT2-inhibitor
- Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment
- Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.
The study team makes the final eligibility decision.
Where it is enrolling
- Groningen, Provincie Groningen, Netherlands
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, but 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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Groningen, Provincie Groningen, Netherlands. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.