Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
100
Countries
1
Sites
1
Heart failure, cardiovascular disease, chronic kidney disease
The main objective of this study in patients with heart failure (HF) or cardiovascular disease (CVD) and chronic kidney disease (CKD) is to compare the effects of the ASi, vicadrostat, with the steroidal MRA, spironolactone, on the change in kidney function from baseline to 4 and 26 weeks.
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 7 Apr 2026 → ongoing
- Decision date (initial)
- 2026-03-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Boehringer Ingelheim International GmbH
External identifiers
- EU CT number
- 2025-523743-35-00
- ClinicalTrials.gov
- NCT07304817
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others
The main objective of this study in patients with heart failure (HF) or cardiovascular disease (CVD) and chronic kidney disease (CKD) is to compare the effects of the ASi, vicadrostat, with the steroidal MRA, spironolactone, on the change in kidney function from baseline to 4 and 26 weeks.
Secondary objectives 4
- Changes in renal hemodynamic measurements from baseline to 4 and 26 weeks.
- Changes in urinary and plasma protein profiles from base line to 4 and 26 weeks
- Changes in blood (serum and plasma) concentrations of potassium, creatinine, neutrophil gelatinase-associated lipocalin (NGAL), renin, angiotensin II, aldosterone, and kidney injury molecule-1 (KIM-1) from baseline to 4 and 26 weeks
- Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks.
Conditions and MedDRA coding
Heart failure, cardiovascular disease, chronic kidney disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.1 | PT | 10064848 | Chronic kidney disease | 100000004857 |
| 20.1 | LLT | 10007648 | Cardiovascular disease unspecified | 10007541 |
| 20.0 | LLT | 10008908 | Chronic heart failure | 10007541 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Single period, randomized open label 26 weeks of treatment
|
Randomised Controlled | None | Spironolactone + Empagliflozin: Comparator IMP + AxMP Vicadrostat + Empagliflozin: IMP + AxMP |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 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 background 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
Exclusion criteria 5
- 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.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint for kidney function is the change in eGFR baseline to 4 and 26 weeks of treatment
Secondary endpoints 3
- The endpoints for the renal hemodynamic changes includes measured glomerular filtration rate (mGFR), effective renal plasma flow (ERPF), renal blood flow (RBF), renal vascular resistance (RVR), glomerular pressure (Pglo), afferent vascular resistance (Ra) and efferent vascular resistance (Re) at baseline and after 4 and 26 weeks of treatment
- Endpoints related to plasma and urinary protein profiles are the difference in changes in their profiles between vicadrostat and spironolactone after 4 and 26 weeks of treatment
- Changes in UACR and urinary concentration of sodium, NGAL, and KIM-1 from baseline to 4 and 26 weeks
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11187391 · Product
- Active substance
- BI 690517
- Pharmaceutical form
- FILM COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1890 mg milligram(s)
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Spironolacton Accord 25 mg filmomhulde tabletten
PRD341813 · Product
- Active substance
- Spironolactone
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 8925 mg milligram(s)
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Authorised
- ATC code
- C03DA01 — SPIRONOLACTONE
- Marketing authorisation
- RVG 24025
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The comparator product Spironolactone will be subject to secondary repackaging and relabelling for the purposes of the clinical trial. The medicinal product will be placed into new outer cartons in order to reflect the study-specific quantities, and a clinical trial label will be applied. No changes will be made to the primary packaging or to the formulation of the product. As the primary container remains unchanged, the stability, quality and integrity of the medicinal product are not impacted.
Auxiliary 3
—
SCP2100749 · ATC
- Route of administration
- INFUSION
- Max daily dose
- 6 mg/kg milligram(s)/kilogram
- Max total dose
- 18 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CH30 — AMINOHIPPURIC ACID
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD379264 · Product
- Active substance
- Iohexol
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 36 mg/kg milligram(s)/kilogram
- Max total dose
- 36 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V08AB02 — IOHEXOL
- Marketing authorisation
- RVG 09821
- MA holder
- GE HEALTHCARE B.V.
- MA country
- Netherlands
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Jardiance 10 mg film-coated tablets
PRD1594873 · Product
- Active substance
- Empagliflozin
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 1890 mg milligram(s)
- Max treatment duration
- 27 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BK03 — -
- Marketing authorisation
- EU/1/14/930/018
- MA holder
- BOEHRINGER INGELHEIM INTERNATIONAL GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Kevin Damman
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Kevin Damman
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 100 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Delphinium B.V.
-, Hanzeplein 1, 9713 GZ, Groningen
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Netherlands | 2026-04-07 | 2026-05-07 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_redacted 2025-523743-35-00 | 2.0 |
| Protocol (for publication) | D1_Protocol_Redacted_ 2025-523743-35-00_TC | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements 2025-523743-35-00 | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults description_ redacted 2025-523743-35-00 | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults description_ redacted 2025-523743-35-00_TC | 2.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Spironolactone_Accord | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol samenvatting_NL_2025-523743-35-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2025-523743-35-00 | 2.0 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-23 | Netherlands | Acceptable 2026-03-19
|
2026-03-23 |