A study to test whether vicadrostat in combination with empagliflozin helps people with chronic kidney disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

28 Aug 2025 → ongoing

Decision date (initial)

2025-08-05

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518457-42-00

WHO UTN

U1111-1314-0083

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

The primary objective is to compare staggered vs simultaneous initiation of vicadrostat in combination with empagliflozin for the absolute change in eGFR from baseline to Week 14 and week 16

Secondary objectives 1

1. Secondary objectives are also to compare staggered vs simultaneous initiation of vicadrostat in combination with empagliflozin for absolute changes in estimated glomerular filtration rate (eGFR), Systolic blood pressure (SBP), and serum potassium levels from baseline to Week 12 and relative change in urine albumin creatinine ratio (UACR) from baseline to Week 6.

Conditions and MedDRA coding

chronic kidney disease

Regulatory references

Scientific advice from competent authorities

Pharmaceuticals And Medical Devices Agency

Plan to share IPD

Yes

IPD plan description

"Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed “Document Sharing Agreement”. Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined on the website. Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program. Access Criteria: For study documents – upon signing of a ‚Document Sharing Agreement‘. For study data – 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement."

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. At least 18 years old and at least of the legal age of consent in countries where it is greater than 18 years.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female participants. WOCBP must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. For men, birth control is not required during the trial.
4. Evidence of CKD at risk of progression based on two eGFR measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each eGFR ≥20 and <60 mL/min/1.73m2, irrespective of UACR. The first of these measurements will be assessed from historical local laboratory results, and the second will be determined from serum creatinine analysed by the central laboratory at Visit 1
5. Treatment with a clinically appropriate, stable dose of either ACEi or ARB (but not both together) for ≥4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial

Exclusion criteria 9

1. Treatment with an SGLT2i within 4 weeks before Visit 2. Treatment with an SGLT2i should not be interrupted with the intention of enrolment into the trial.
2. Treatment with an MRA, ASi, or potassium-sparing diuretic(s) within 14 days prior to Visit 1, or requiring such treatment before randomisation, or planned during the trial, based on the judgment of the investigator. Treatment with an MRA or ASi should not be interrupted with the intention of enrolment into the trial.
3. Blood potassium of >5.2 mmol/L measured by the central laboratory at Visit 1. (Note: One reassessment of serum potassium is allowed during screening)
4. Blood ALT or AST >3x ULN at Visit 1.
5. Known severe hepatic impairment (i.e. Child Pugh class C cirrhosis).
6. On dialysis, functioning kidney transplant, or scheduled for transplant.
7. Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days.
8. Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone).
9. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 14 and week 16

Secondary endpoints 4

1. Absolute change in eGFR (mL/min/1.73m2) from baseline to Week 12
2. Absolute change in SBP (mmHg) from baseline to Week 12
3. Relative change (ratio) in UACR from baseline to Week 6
4. Absolute change in serum potassium (mmol/L) from baseline to Week 12

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

8 EU/EEA countries · 40 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 110 files

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

Application history

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