Register a trial

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


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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.
  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/NCT06531824




Registration number
NCT06531824
Ethics application status
Date submitted
29/07/2024
Date registered
1/08/2024

Titles & IDs
Public title
EASi-KIDNEY™ (The Studies of Heart & Kidney Protection With BI 690517 in Combination With Empagliflozin)
Scientific title
A Multicenter, International, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Aldosterone Synthase Inhibitor BI 690517 in Combination With Empagliflozin in Patients With Chronic Kidney Disease
Secondary ID [1] 0 0
2024-511025-63-00
Secondary ID [2] 0 0
1378-0006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Disease, Chronic 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 - BI 690517
Treatment: Drugs - Placebo matching BI 690517
Treatment: Drugs - Empagliflozin

Other: Part 1: Run-in period (all participants) - Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin.

Experimental: Part 2: Randomized treatment, follow-up period, treatment group -

Placebo comparator: Part 2: Follow-up period, placebo group -


Treatment: Drugs: BI 690517
BI 690517

Treatment: Drugs: Placebo matching BI 690517
Placebo matching BI 690517

Treatment: Drugs: Empagliflozin
Empagliflozin
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression*; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.
Timepoint [1] 0 0
up to 4 years
Secondary outcome [1] 0 0
Key secondary outcome: Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope)
Timepoint [1] 0 0
up to 4 years
Secondary outcome [2] 0 0
Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death
Timepoint [2] 0 0
up to 4 years
Secondary outcome [3] 0 0
Time to kidney disease progression
Timepoint [3] 0 0
up to 4 years
Secondary outcome [4] 0 0
Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death
Timepoint [4] 0 0
up to 4 years
Secondary outcome [5] 0 0
Occurrences of hospitalizations from any cause (first and any subsequent, combined)
Timepoint [5] 0 0
up to 4 years
Secondary outcome [6] 0 0
Time to first event of kidney disease progression or cardiovascular death
Timepoint [6] 0 0
up to 4 years
Secondary outcome [7] 0 0
Time to death from any cause
Timepoint [7] 0 0
up to 4 years

Eligibility
Key inclusion criteria
Key

* Evidence of chronic kidney disease (CKD) at risk of kidney disease progression is defined on the basis of local laboratory results recorded at least 3 months before and at the time of the Screening visit, and requires:

1. Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) eGFR =20 <45 mL/min/1.73m²; or
2. CKD-EPI eGFR =45 <90 mL/min/1.73m² with urine albumin-to-creatinine ratio (uACR) =200 mg/g (or protein-to-creatinine ratio =300 mg/g).
* Neither requires an Aldosterone Synthase inhibitor (ASi) or Mineralocorticoid Receptor Antagonist (MRA), nor that such treatment is definitely inappropriate.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Blood potassium of >5.2 mmol/L at screening visit
* Blood Alanine Transaminase (ALT) or Aspartate Transaminase (AST) >3x Upper Limit of Normal (ULN) at Screening visit
* Known liver cirrhosis
* On dialysis, functioning kidney transplant, or scheduled living donor transplant
* Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days
* Receiving more than one Renin-Angiotensin System (RAS) inhibitor (i.e. on dual therapy with two of an Angiotensin-Converting Enzyme inhibitor (ACEi), Angiotensin Receptor Blocker (ARB) or direct renin inhibitor)
* Currently treated with an Mineralocorticoid Receptor Antagonist (MRA) (e.g. spironolactone, eplerenone, finerenone)
* 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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/08/2028
Actual
Sample size
Target
11000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
New Hampshire
Country [6] 0 0
United States of America
State/province [6] 0 0
North Carolina
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Denmark
State/province [8] 0 0
København
Country [9] 0 0
Denmark
State/province [9] 0 0
Roskilde
Country [10] 0 0
Germany
State/province [10] 0 0
Dortmund
Country [11] 0 0
Germany
State/province [11] 0 0
Freiburg
Country [12] 0 0
Germany
State/province [12] 0 0
Heilbronn
Country [13] 0 0
Germany
State/province [13] 0 0
München
Country [14] 0 0
Germany
State/province [14] 0 0
Rotenburg
Country [15] 0 0
Germany
State/province [15] 0 0
Schweinfurt
Country [16] 0 0
Germany
State/province [16] 0 0
Stuttgart
Country [17] 0 0
Germany
State/province [17] 0 0
Würzburg
Country [18] 0 0
Italy
State/province [18] 0 0
Bologna
Country [19] 0 0
Italy
State/province [19] 0 0
Firenze
Country [20] 0 0
Italy
State/province [20] 0 0
Pavia
Country [21] 0 0
Italy
State/province [21] 0 0
Prato
Country [22] 0 0
Italy
State/province [22] 0 0
Roma
Country [23] 0 0
Italy
State/province [23] 0 0
San Giovanni Rotondo (Foggia)
Country [24] 0 0
Italy
State/province [24] 0 0
Verbania
Country [25] 0 0
Malaysia
State/province [25] 0 0
Batu Caves
Country [26] 0 0
Malaysia
State/province [26] 0 0
Ipoh
Country [27] 0 0
Malaysia
State/province [27] 0 0
Kajang, Selangor
Country [28] 0 0
Malaysia
State/province [28] 0 0
Klang
Country [29] 0 0
Malaysia
State/province [29] 0 0
Kota Kinabalu
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Malaysia
State/province [31] 0 0
Kuala Pilah
Country [32] 0 0
Malaysia
State/province [32] 0 0
Kuching
Country [33] 0 0
Malaysia
State/province [33] 0 0
Melaka
Country [34] 0 0
Malaysia
State/province [34] 0 0
Serdang
Country [35] 0 0
Malaysia
State/province [35] 0 0
Seremban
Country [36] 0 0
Malaysia
State/province [36] 0 0
Temerloh
Country [37] 0 0
Taiwan
State/province [37] 0 0
New Taipei City
Country [38] 0 0
Taiwan
State/province [38] 0 0
Taipei
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Bristol
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Bury St Edmunds
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Dorset
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Gloucester
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Oxford
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Pickering

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/NCT06531824