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Clinical trial Recruiting at 2 sites Phase 2 Interventional Ages 18 and up

Vicadrostat versus spironolactone: effects on kidney function and protein markers

Official title: Comparative Study on the Mode of Action of Vicadrostat and Spironolactone on Protein Profiles and Renal Hemodynamic Effects in Patients Chronic Kidney Disease With Cardiovascular Disease /Heart Failure

Run by University Medical Center Groningen · NCT07304817 · Data updated 2026-11-12

This will test whether vicadrostat or spironolactone, each given with empagliflozin, changes kidney function and blood/urine protein patterns in adults with CKD and heart disease or heart failure.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity Medical Center Groningen
Academic / other
Locations2 sites (Groningen, Provincie Groningen and 1 other locations)
StatusRecruiting
StartedMay 12, 2026
Main results expectedFebruary 2028
Study endsFebruary 2028
Registry record updatedMay 29, 2026
Trial IDNCT07304817 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with chronic kidney disease and either heart failure (any LVEF) or established cardiovascular disease, with eGFR in the protocol-specified ranges (25–90 or 25–60 mL/min/1.73 m2 depending on subgroup), serum potassium ≤5.0 mmol/L, eligible for empagliflozin, not on an MRA or ASI in the prior 6 months, and stable on other guideline therapies are eligible.

Probably not a fit

People with eGFR outside the allowed ranges, serum potassium >5.0 mmol/L, recent use of MRAs/ASIs, or who are unable or ineligible to take empagliflozin are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, open-label, parallel-group trial with 1:1 randomization and blinded endpoint assessment comparing vicadrostat (10 mg daily) to spironolactone (25–50 mg daily) on a background of empagliflozin (10 mg daily) for 26 weeks. The primary focus is change in kidney function from baseline to 4 and 26 weeks, with secondary measures including renal hemodynamics and plasma/urinary proteomic profiles. Approximately half of participants (target ~50) will undergo detailed renal hemodynamic testing at baseline, 4 and 26 weeks. The trial enrolls adults with CKD who also have heart failure or established cardiovascular disease to explore mechanistic differences between an aldosterone synthase inhibitor and a mineralocorticoid receptor antagonist.

Why it matters

Potential benefit: If successful, the trial could identify whether vicadrostat provides equal or better kidney protection than spironolactone and help guide safer, more targeted aldosterone-directed therapy for people with CKD and cardiovascular disease.

How similar studies have gone: Steroidal MRAs like spironolactone have evidence for benefit in heart failure but carry hyperkalemia risk, while ASIs such as vicadrostat are a newer approach with limited clinical outcome data and no prior direct head-to-head renal comparisons.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Provided written and dated informed consent for participation prior to trial admission,
2. Age ≥18 years, female or male
3. 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
4. Serum potassium ≤ 5.0 mmol
5. Currently treated or eligible for treatment with Empagliflozin\*4
6. Not using a MRA or AS inhibitor in the last 6 months prior to enrollment
7. On stable doses of other guideline directed medical therapies for ≥ 4 weeks prior to enroll-ment
8. 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 subjects can be enrolled directly. If the subject is not yet on SGLT2i and starts Empagliflozin enrollment can start 4 weeks later see criteria 8.

Exclusion Criteria:

1. Inability to understand and sign informed consent
2. Absolute contra-indication for aldosterone antagonist
3. Absolute contra-indication for a SGLT2-inhibitor
4. Heart failure hospitalization, acute coronary syndrome, cardiac surgery, stroke or transient is-chemic attack in the 90 days prior to enrollment
5. Women who are pregnant, breastfeeding or may be considering pregnancy during the study duration.

Where it's running

  • Delphinium
    Groningen, Provincie Groningen, Netherlands     Recruiting
  • University Medical Center Groningen
    Groningen, Provincie Groningen, Netherlands     Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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CKD 20Cardiovascular Diseases 365Heart Failure 1020University Medical Center Groningen 94
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.