Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: BI 690517: 10mg once daily
Control Intervention1: BI690517 Placebo: NA
Sponsors
Boehringer Ingelheim
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age is �18 years at Screening; 2. There is evidence of CKD at risk of kidney disease progression 3. A local investigator judges that the potential participant: a. Neither requires an ASi or MRA, nor that such treatment is definitely inappropriate (i.e. the uncertainty principle) b. Is treated with an investigator-judged clinically appropriate dose of a RAS inhibitor, unless such treatment is either not tolerated or not indicated; c. Can initiate empagliflozin 10mg daily when not already treated, or are able to switch to empagliflozin 10mg daily where already treated with a different SGLT inhibitor.
Exclusion criteria
Exclusion criteria: 1.Blood potassium of more than 5.2 mmolLs at screening visit 2.Blood ALT or AST More than 3x ULN at Screening visit 3.Known liver cirrhosis 4.On dialysis, functioning kidney transplant, or scheduled living donor transplant 5.Treated with new immunosuppression therapy for new (or relapse/flare of pre-existing) kidney disease within the last 60 days 6.Receiving more than one RAS inhibitor (i.e. on dual therapy with two of an ACEi, ARB or direct renin inhibitor) 7.Currently treated with an MRA (e.g. spironolactone, eplerenone, finerenone) 8.Currently treated with systemic mineralocorticoid replacement therapy (e.g. fludrocortisone) 9.Known Cushingââ?¬•s syndrome 10.Known adrenal cortisol insufficiency 11.Hypersensitivity (i.e. allergic reaction or anaphylaxis) to ASi 12.Use of an investigational medicinal product in the 30 days prior to Screening visit 13.Symptomatic hypotension, or systolic blood pressure less than 100 or more than 180 mmHg (using local blood pressure machine) 14.Known to be poorly compliant with clinic visits or prescribed medication 15.History that might limit the individualââ?¬•s ability to report medical information reliably (e.g. known dementia, recent history of alcohol or substance misuse, or difficulty answering Screening visit questions); or limit ability to take study treatments for the duration of the study (e.g. terminal respiratory disease; history of invasive cancer or evidence of cancer spread within the last 3 years [excluding low-grade canceru]) 16.Current pregnancy, lactation or women of childbearing potential, unless using highly effective contraception 17.Hypersensitivity (i.e. allergic reaction or anaphylaxis) to SGLT2 inhibitor 18.Type 1 diabetes mellitus 19.Ketoacidosis in last 5 years 20.Polycystic kidney disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kidney disease progression (defined as kidney failureââ?¬Â or a sustained ââ?°Â¥40% decline in eGFR from randomization); or Hospitalization for heart failure; or Cardiovascular death Timepoint: From Randomisation to End of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Annual rate of change in eGFR from 3 months until last scheduled visit (i.e. chronic eGFR slope) 2.Time to first event of kidney failure, hospitalization for heart failure or cardiovascular death 3.Time to kidney disease progression; 4.Occurrences of hospitalizations for heart failure (first & any subsequent, combined) or cardiovascular death 5.Occurrences of hospitalizations from any cause (first & any subsequent, combined) Timepoint: From Randomisation to End of the study | — |
Countries
Argentina, Australia, Brazil, Canada, China, Denmark, Germany, India, Italy, Japan, Malaysia, Mexico, New Zealand, Portugal, Republic of Korea, Taiwan, United Kingdom, United States of America
Contacts
Public ContactNiranjana Gangadharan
George Institute Services India Pvt Ltd
Outcome results
None listed