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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06926660
Registration number
NCT06926660
Ethics application status
Date submitted
11/04/2025
Date registered
14/04/2025
Date last updated
9/07/2025
Titles & IDs
Public title
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
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Scientific title
A Phase II Randomised, Double-blind, Parallel-group, Multicentre, International Trial to Investigate the Safety and Efficacy of Vicadrostat and Empagliflozin Administered With Simultaneous vs Staggered Initiation in Participants With Chronic Kidney Disease at Risk of Kidney Disease Progression
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Secondary ID [1]
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2024-518457-42-00
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Secondary ID [2]
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1378-0023
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease
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0
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Condition category
Condition code
Renal and Urogenital
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0
0
0
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Kidney disease
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Renal and Urogenital
0
0
0
0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Vicadrostat
Treatment: Drugs - Empagliflozin
Treatment: Drugs - Placebo matching vicadrostat
Placebo comparator: Placebo followed by vicadrostat + empagliflozin -
Experimental: Vicadrostat + empagliflozin -
Treatment: Drugs: Vicadrostat
Vicadrostat
Treatment: Drugs: Empagliflozin
Empagliflozin
Treatment: Drugs: Placebo matching vicadrostat
Placebo matching vicadrostat
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14
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Assessment method [1]
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0
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Timepoint [1]
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At baseline, up to week 14
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Secondary outcome [1]
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Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 12
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Assessment method [1]
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0
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Timepoint [1]
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At baseline, up to week 12
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Secondary outcome [2]
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Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 12
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Assessment method [2]
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0
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Timepoint [2]
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At baseline, up to week 12
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Secondary outcome [3]
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Relative change (ratio) in Urine Albumin Creatinine Ratio (UACR) from baseline to Week 6
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Assessment method [3]
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0
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Timepoint [3]
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At baseline, up to week 6
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Secondary outcome [4]
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Absolute change in serum potassium (mmol/L) from baseline to Week 12
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Assessment method [4]
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0
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Timepoint [4]
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At baseline, up to week 12
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Eligibility
Key inclusion criteria
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. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council on Harmonisation (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. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information.
4. Evidence of Chronic Kidney Disease (CKD) at risk of progression based on two Estimated Glomerular Filtration Rate (eGFR) measurements recorded recently (i.e. within 1 year) and at the time of Visit 1, with each Estimated Glomerular Filtration Rate (eGFR) =20 and <60 mL/min/1.73m2, irrespective of urine albumin creatinine ratio (UACR). The first of these measurements will be In Approval 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 Angiotensin-converting enzyme inhibitor (ACEi) or Angiotensin II Receptor Blockers (ARB) (but not both together) for =4 weeks before Visit 1, with no planned changes of the therapy for the duration of the trial.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Treatment with an SGLT2i within 4 weeks before Visit 2. Treatment with a sodium glucose co transporter 2 inhibitor (SGLT2i) should not be interrupted with the intention of enrolment into the trial.
2. Treatment with an mineralocorticoid receptor antagonist (MRA), aldosterone synthase inhibitor (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 at Visit 1.
4. Blood Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >3x Upper limit of normal (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).
Further exclusion criteria apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
11/07/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
8/01/2027
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Actual
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Sample size
Target
416
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Westmead Hospital - Westmead
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Northern Hospital Epping - Epping
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Royal Perth Hospital - Perth
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2305 - New Lambton Heights
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2145 - Westmead
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3076 - Epping
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6000 - Perth
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Funding & Sponsors
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Name
Boehringer Ingelheim
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Ethics approval
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Summary
Brief summary
This study is open to adults with chronic kidney disease (CKD) that is at risk of getting worse. People who have taken a specific type of medication for kidney disease called SGLT2 inhibitor within 1 month before the study or have certain health conditions cannot take part in this study. The purpose of this study is to find out whether a medicine called vicadrostat, used in combination with another medicine called empagliflozin, works in people with chronic kidney disease. In this study, participants are randomly assigned to one of two groups. Participants have an equal chance of being assigned to either group. In one group, participants take the 2 study medicines, vicadrostat and empagliflozin, every day for 3 months. In the other group, participants take placebo and empagliflozin for the first 1.5 months, and then they take vicadrostat and empagliflozin together for the next 1.5 months. The study medicines are taken orally as tablets. Placebo tablets look like vicadrostat tablets but do not contain any medicine. Participants are in the study for about 4 months. During this time, they visit the study site multiple times. Doctors regularly test kidney function by measuring specific proteins in the blood and urine. The results are compared between the two groups to see whether there are differences between starting the study medicines at the same time or one after the other. The doctors also regularly check participants' health and take note of any unwanted effects.
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Trial website
https://clinicaltrials.gov/study/NCT06926660
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Contacts
Principal investigator
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Contact person for public queries
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Boehringer Ingelheim
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Phone
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1-800-243-0127
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Once the criteria in section 'time frame' are fulfilled, 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 in the website.
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When will data be available (start and end dates)?
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.
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Available to whom?
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'spublication plan); 2. and upon signing of a legal agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06926660
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