Chronic Kidney Disease
Conditions
Interventions
Run-in period (all participants)
- Eligible participants will enter a Run-in period during which they will receive placebo matching BI 690517 + empagliflozin.
- Randomized treatment, follow-up period
Sponsors
Herrington Will
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first occurrence of the primary composite outcome of: (i) Kidney disease progression; or (ii) Hospitalization for heart failure; or (iii) Cardiovascular death. | — |
Secondary
| Measure | Time frame |
|---|---|
| Annual rate of change in eGFR from 3 month visit until last scheduled visit (i.e. chronic eGFR slope) | — |
Countries
Argentina, Australia, Brazil, Canada, China, Denmark, Germany, India, Italy, Japan, Malaysia, Mexico, New Zealand, Portugal, South Korea, Taiwan, UK, USA
Contacts
Public ContactChikako Rosario
Parexel International Inc.
Outcome results
None listed