chronic kidney disease
Conditions
Interventions
Drug: BI 690517, Placebo to BI 690517, Empagliflozin, Placebo to empagliflozin
Sponsors
Imazu Susumu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. - Male or female patients of legal adult age (according to local legislation) and aged >= 18 years at time of consent. - estimated Glomerular Filtration Rate (eGFR, Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI) formula] >= 30 and = 200 and = 4 weeks prior to visit 1 and until first randomisation with no planned change of the therapy during the trial. - In the Investigator's opinion, one or more of the following underlying kidney disease causes: #Diabetic kidney disease. These patients must have type 2 diabetes mellitus and their treatment (including Glucagon-Like Peptide-1 (GLP1) receptor agonist) should be unchanged or changes deemed minor (according to investigator's judgement) within 4 weeks prior to Visit 1 and until first randomisation. #Hypertensive kidney disease #Chronic glomerulonephritis defined as one of the following: Immunoglobulin A (IgA) nephropathy, Membranous nephropathy, Focal Segmental Glomerulosclerosis (FSGS) - Glycated Haemoglobin (HbA1c) = 110 and = 65 and = 18.5 and = 20 mL/min/1.73 m2 measured by local or central laboratory within 7 days prior to randomisation to the Treatment Period.
Exclusion criteria
Exclusion criteria: - 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. - Treatment with other Renin Angiotensin Aldosterone System (RAAS) interventions (apart from either Angiotensin-Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB)) within 4 weeks prior to Visit 1 and throughout screening or planned during the trial. Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial are also excluded. - Type 1 diabetes mellitus, or history of other autoimmune causes of diabetes mellitus (e.g. Latent Autoimmune Diabetes (LADA)) - Patients at increased risk of ketoacidosis in the opinion of the investigator. - Currently receiving Sodium-glucose cotransporter (SGLT)-2 or SGLT-1/2 inhibitor or planned initiation during the trial. Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from treatment period baseline in log transformed Urine Albumin Creatinine Ratio (UACR) measured in First Morning Void urine [ Time Frame: up to 14 weeks ] | — |
Secondary
| Measure | Time frame |
|---|---|
| - UACR response I, defined as decrease of at least 30% absolute change in First Morning Void urine of UACR from treatment period baseline [ Time Frame: up to 14 weeks ] - UACR response II, defined as decrease of at least 15% absolute change in First Morning Void urine of UACR from treatment period baseline [ Time Frame: up to 14 weeks ] | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Switzerland
Contacts
Public ContactShizuko Kawahara
Boehringer Ingelheim
Outcome results
None listed