chronic kidney disease MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: BI 690517
Product Code: BI 690517
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BI 690517
CAS Number: *MASKED*
Current Sponsor code: BI 690517
Other descriptive name: BI 6
Sponsors
Boehringer Ingelheim SComm
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. 2. Male or female patients aged = 18 years at time of consent. 3. eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula) = 30 and =65 years) yes F.1.3.1 Number of subjects for this age range 252
Exclusion criteria
Exclusion criteria: 1. Treatment with inhibitors of aldosterone mediated effects (e.g., mineralocorticoid receptor antagonists such as spironolactone), or intake of other potassium sparing diuretics (e.g., amiloride) within 7 days prior to first randomisation or planned during trial treatment phase. 2. Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either ACEi or ARB) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. 3. Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. LADA) 4. Patients at increased risk of ketoacidosis in the opinion of the investigator. 5. Currently receiving SGLT-2 or SGLT-1/2 inhibitor or planned initiation during the trial. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The trial will compare 3 doses of BI 690517 with placebo in patients with diabetic and nondiabetic CKD randomised to empagliflozin or placebo as background therapy (established during the randomised run-in).;Secondary Objective: Secondary objectives will be as above but in subpopulations of (1) placebo background therapy (2) empagliflozin background therapy.;Primary end point(s): Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine after 14 weeks.;Timepoint(s) of evaluation of this end point: 14 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks. 2) UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline to 14 weeks.;Timepoint(s) of evaluation of this end point: 1) 14 weeks 2) 14 weeks | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Korea, Republic of, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Switzerland, Türkiye, Ukraine, United States, Viet Nam
Contacts
Public ContactCT Disclosure & Data Transparency
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed