Register a trial

Please note that the ANZCTR will be unattended on Friday 25th April due to the ANZAC Day public holiday. Submissions and updates will not be processed during that time.

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.



Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements. New passwords must include at least one lowercase letter, one uppercase letter, one number and one special character (e.g. !#$%&@).
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

Titles & IDs
Public title
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease
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
Secondary ID [1] 0 0
2024-518457-42-00
Secondary ID [2] 0 0
1378-0023
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 14
Timepoint [1] 0 0
At baseline, up to week 14
Secondary outcome [1] 0 0
Absolute change in estimated glomerular filtration rate (eGFR) (mL/min/1.73m2) from baseline to Week 12
Timepoint [1] 0 0
At baseline, up to week 12
Secondary outcome [2] 0 0
Absolute change in systolic blood pressure (SBP) (mmHg) from baseline to Week 12
Timepoint [2] 0 0
At baseline, up to week 12
Secondary outcome [3] 0 0
Relative change (ratio) in Urine Albumin Creatinine Ratio (UACR) from baseline to Week 6
Timepoint [3] 0 0
At baseline, up to week 6
Secondary outcome [4] 0 0
Absolute change in serum potassium (mmol/L) from baseline to Week 12
Timepoint [4] 0 0
At baseline, up to week 12

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
16/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
8/01/2027
Actual
Sample size
Target
416
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Northern Hospital Epping - Epping
Recruitment hospital [3] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
3076 - Epping
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Caba
Country [2] 0 0
Argentina
State/province [2] 0 0
Capital Federal
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad Autonoma de Buenos Aires
Country [4] 0 0
Argentina
State/province [4] 0 0
Rosario
Country [5] 0 0
Argentina
State/province [5] 0 0
Villa Luro
Country [6] 0 0
Belgium
State/province [6] 0 0
Bruxelles
Country [7] 0 0
Belgium
State/province [7] 0 0
Leuven
Country [8] 0 0
Belgium
State/province [8] 0 0
Lodelinsart
Country [9] 0 0
Brazil
State/province [9] 0 0
Belo Horizonte
Country [10] 0 0
Brazil
State/province [10] 0 0
Porto Alegre
Country [11] 0 0
Brazil
State/province [11] 0 0
São José do Rio Preto
Country [12] 0 0
China
State/province [12] 0 0
Chengdu
Country [13] 0 0
China
State/province [13] 0 0
Hangzhou
Country [14] 0 0
China
State/province [14] 0 0
Jinan
Country [15] 0 0
China
State/province [15] 0 0
Nanchang
Country [16] 0 0
Czechia
State/province [16] 0 0
Havirov
Country [17] 0 0
Czechia
State/province [17] 0 0
Pribram
Country [18] 0 0
Czechia
State/province [18] 0 0
Slany
Country [19] 0 0
France
State/province [19] 0 0
Le Kremlin-Bicêtre
Country [20] 0 0
France
State/province [20] 0 0
Nantes
Country [21] 0 0
France
State/province [21] 0 0
Strasbourg
Country [22] 0 0
Germany
State/province [22] 0 0
Berlin
Country [23] 0 0
Germany
State/province [23] 0 0
Bielefeld
Country [24] 0 0
Germany
State/province [24] 0 0
Bünde
Country [25] 0 0
Germany
State/province [25] 0 0
Dresden
Country [26] 0 0
Germany
State/province [26] 0 0
Frankfurt
Country [27] 0 0
Germany
State/province [27] 0 0
Geilenkirchen
Country [28] 0 0
Germany
State/province [28] 0 0
Hannover
Country [29] 0 0
Germany
State/province [29] 0 0
Leipzig
Country [30] 0 0
Germany
State/province [30] 0 0
Rotenburg
Country [31] 0 0
Germany
State/province [31] 0 0
Wiesbaden
Country [32] 0 0
Italy
State/province [32] 0 0
Chieti
Country [33] 0 0
Italy
State/province [33] 0 0
Perugia
Country [34] 0 0
Italy
State/province [34] 0 0
Ranica (BG)
Country [35] 0 0
Italy
State/province [35] 0 0
Roma
Country [36] 0 0
Japan
State/province [36] 0 0
Aichi, Kasugai
Country [37] 0 0
Japan
State/province [37] 0 0
Ibaraki, Tsuchiura
Country [38] 0 0
Japan
State/province [38] 0 0
Kanagawa, Yokohama
Country [39] 0 0
Japan
State/province [39] 0 0
Saitama, Ageo
Country [40] 0 0
Japan
State/province [40] 0 0
Shiga, Omihachiman
Country [41] 0 0
Japan
State/province [41] 0 0
Tokyo, Hachioji
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Seongnam
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Seoul
Country [44] 0 0
Netherlands
State/province [44] 0 0
Amsterdam
Country [45] 0 0
Netherlands
State/province [45] 0 0
Dordrecht
Country [46] 0 0
Netherlands
State/province [46] 0 0
Eindhoven
Country [47] 0 0
Netherlands
State/province [47] 0 0
Hoogeveen
Country [48] 0 0
New Zealand
State/province [48] 0 0
Dunedin
Country [49] 0 0
New Zealand
State/province [49] 0 0
Hamilton
Country [50] 0 0
Philippines
State/province [50] 0 0
Quezon City
Country [51] 0 0
Poland
State/province [51] 0 0
Bydgoszcz
Country [52] 0 0
Poland
State/province [52] 0 0
Chrzanow
Country [53] 0 0
Poland
State/province [53] 0 0
Katowice
Country [54] 0 0
Poland
State/province [54] 0 0
Lodz
Country [55] 0 0
Poland
State/province [55] 0 0
Tczew
Country [56] 0 0
Spain
State/province [56] 0 0
A Coruña
Country [57] 0 0
Spain
State/province [57] 0 0
Barcelona
Country [58] 0 0
Spain
State/province [58] 0 0
Cartagena
Country [59] 0 0
Spain
State/province [59] 0 0
Osona, Barcelona
Country [60] 0 0
Spain
State/province [60] 0 0
Oviedo
Country [61] 0 0
Spain
State/province [61] 0 0
Salamanca
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taichung
Country [63] 0 0
Taiwan
State/province [63] 0 0
Taipei
Country [64] 0 0
Thailand
State/province [64] 0 0
Bangkok
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Glasgow
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Boehringer Ingelheim
Address 0 0
Country 0 0
Phone 0 0
1-800-243-0127
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


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