Clinical trial • Phase III • Nephrology|Cardiology
BI 690517 for Chronic kidney disease
Phase III trial of BI 690517 for Chronic kidney disease.
Overview
- Trial Therapeutic Area
- Nephrology|Cardiology
- Trial Disease
- Chronic kidney disease
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 10-04-2024
- First CTIS Authorization Date
- 30-07-2024
Trial design
Randomised, randomized arms: bi 690517 (oral film-coated tablet, max daily dose 10 mg) versus matching placebo (placebo tablet matching bi690517), with all participants receiving background open-label empagliflozin (jardiance 10 mg film-coated tablets, oral). run-in period: single-blind placebo bi 690517 tablets + open-label empagliflozin.-controlled Phase III trial in Portugal, Germany, Denmark and others.
- Randomised
- Yes
- Comparator
- Randomized arms: BI 690517 (oral film-coated tablet, max daily dose 10 mg) versus matching placebo (Placebo tablet matching BI690517), with all participants receiving background open-label empagliflozin (Jardiance 10 mg film-coated tablets, oral). Run-in period: single-blind placebo BI 690517 tablets + open-label empagliflozin.
- Target Sample Size
- 9000
- Trial Duration For Participant
- 1440
Stratification factors
- Self-reported diabetes status / use of certain glucose-lowering medication
- Age
- Sex
- eGFR
- uACR
- Blood potassium
- Region
Eligibility
Recruits 9000 Vulnerable populations are selected (isVulnerablePopulationSelected = true). Informed consent is required; multiple subject information and informed consent documents are provided (country-specific ICFs and subject information materials listed for PT, GER, DK, SE, IT, BE). No specific details on assent procedures or further consent handling for vulnerable subgroups are provided in the available CTIS data..
- Vulnerable Population
- Vulnerable populations are selected (isVulnerablePopulationSelected = true). Informed consent is required; multiple subject information and informed consent documents are provided (country-specific ICFs and subject information materials listed for PT, GER, DK, SE, IT, BE). No specific details on assent procedures or further consent handling for vulnerable subgroups are provided in the available CTIS data.
Inclusion criteria
- {"criterion_text":"- Age >= 18 years at Screening"}
- {"criterion_text":"- Evidence of 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: (a) CKD-EPI eGFR ≥20 <45 mL/min/1.73m²; or (b) CKD-EPI eGFR ≥45 <90 mL/min/1.73m² with uACR ≥200 mg/g (or protein-to-creatinine ratio ≥300 mg/g)."}
Exclusion criteria
- {"criterion_text":"- Blood potassium of >5.2 mmol/L at Screening visit"}
- {"criterion_text":"- Blood ALT or AST >3x ULN at Screening visit"}
- {"criterion_text":"- Known liver cirrhosis"}
- {"criterion_text":"- On dialysis, functioning kidney transplant, or scheduled living donor transplant"}
- {"criterion_text":"- Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days"}
- {"criterion_text":"- Receiving more than one RAS inhibitor (i.e. on dual therapy with two of an ACEi, ARB or direct renin inhibitor)"}
- {"criterion_text":"- Currently treated with an MRA (e.g. spironolactone, eplerenone, finerenone)"}
- {"criterion_text":"- Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone)"}
- {"criterion_text":"- Further exclusion criteria (see protocol)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression (defined as kidney failure or a sustained decline of ≥40% in eGFR from randomization); or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death.","definition_or_measurement_approach":"Composite time-to-event endpoint measured as time to first occurrence of any component: (i) Kidney disease progression defined as kidney failure or a sustained ≥40% decline in eGFR from randomization; (ii) hospitalization for heart failure; (iii) cardiovascular death."}
Secondary endpoints
- {"endpoint_text":"- Annual rate of change in eGFR from 3 months until last scheduled visit (i.e. chronic eGFR slope)","definition_or_measurement_approach":"Annual rate of change in estimated glomerular filtration rate measured from month 3 until last scheduled visit (chronic eGFR slope)."}
- {"endpoint_text":"- Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death","definition_or_measurement_approach":"Time-to-first-event composite of kidney failure, hospitalization for heart failure, or cardiovascular death."}
- {"endpoint_text":"- Time to kidney disease progression","definition_or_measurement_approach":"Time-to-event for kidney disease progression (as defined in protocol)."}
- {"endpoint_text":"- Occurrences of hospitalizations for heart failure (first and any subsequent, combined) or cardiovascular death","definition_or_measurement_approach":"Counts/time-to-event analysis of hospitalizations for heart failure (first and subsequent combined) or cardiovascular death."}
- {"endpoint_text":"- Occurrences of hospitalizations from any cause (first and any subsequent, combined)","definition_or_measurement_approach":"Counts/time-to-event analysis of all-cause hospitalizations (first and subsequent combined)."}
Recruitment
- Planned Sample Size
- 9000
- Recruitment Window Months
- 48
- Consent Approach
- Informed consent is obtained from participants (multiple country-specific ICFs and subject information documents are provided: Portuguese, German, Danish, Swedish, Italian and Belgium language versions including English/French/Dutch). Participants must be adults (Age ≥ 18 years). A pregnancy-specific consent form is listed among documents. No details about assent for minors (minors are excluded) or additional consent processes for specific vulnerable subgroups are provided in the CTIS data.
Methods
- Country-specific participant invitation letters (documents named 'Participant Invitation letter' present for PT, GER, IT, SE, BE, DK).
- GP / primary care run-in and randomization letters (documents named 'GP Run-in Letter' and 'RunIn HausFacharztbrief' / 'Randomisierung HausFacharztbrief' present for multiple countries).
- Posters and participant flyers (documents named 'Poster' and 'Patientenflyer' present in materials).
- Participant cards and study treatment leaflets (documents named 'Participant Card' and 'Study Treatment Leaflet' present).
- Country-specific recruitment arrangements documents (K1_Recruitment arrangements) are available for Portugal, Germany, Denmark, Italy, Sweden, Belgium indicating tailored, country-level recruitment materials and approaches.
Geography
- Total Number Of Participants
- 2650
Portugal
- Earliest CTIS Part Ii Submission Date
- 03-07-2024
- Latest Decision Or Authorization Date
- 30-07-2024
- Processing Time Days
- 27
- Number Of Participants
- 200
Germany
- Earliest CTIS Part Ii Submission Date
- 17-07-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 14
- Number Of Participants
- 1250
Denmark
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 33
- Number Of Participants
- 150
Italy
- Earliest CTIS Part Ii Submission Date
- 28-06-2024
- Latest Decision Or Authorization Date
- 31-07-2024
- Processing Time Days
- 33
- Number Of Participants
- 750
Sweden
- Earliest CTIS Part Ii Submission Date
- 13-10-2025
- Latest Decision Or Authorization Date
- 14-01-2026
- Processing Time Days
- 93
- Number Of Participants
- 150
Belgium
- Earliest CTIS Part Ii Submission Date
- 19-02-2026
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 18
- Number Of Participants
- 150
Sponsor
Primary sponsor
- Full Name
- Boehringer Ingelheim International GmbH
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Third parties
- {"country":"Denmark","full_name":"RoslevConsulting","duties_or_roles":"Sponsor duties code: 1","organisation_type":"SME"}
Investigational products
- Investigational Product Name
- BI 690517
- Active Substance
- BI 690517
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Investigational (no marketing authorisation listed)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Frequency
- Once daily
- Maximum Dose
- 10 mg
- Investigational Product Name
- Jardiance 10 mg film-coated tablets
- Active Substance
- Empagliflozin
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (EU marketing authorisation EU/1/14/930/010)
- Starting Dose
- 10 mg
- Dose Levels
- 10 mg
- Frequency
- Once daily
- Maximum Dose
- 10 mg
- Investigational Product Name
- Placebo tablet matching BI690517
- Modality
- Other
- Combination Treatment
- Yes
Related trials
Other published trials that may interest you.