Key result
Vicadrostat cuts albuminuria up to ~55% across subgroups with or without background empagliflozin.
Why the study?
The study evaluated the effects of vicadrostat, with or without background empagliflozin, on albuminuria across a range of CKD severity and hypertension status.
Does vicadrostat, with or without background empagliflozin, reduce albuminuria in adults with chronic kidney disease across varying levels of disease severity and hypertension status?
RCT (n=503)
Double-blind
1:1 then 1:1:1:1
Yes
Does vicadrostat, with or without background empagliflozin, reduce albuminuria in adults with chronic kidney disease across varying levels of disease severity and hypertension status?
Vicadrostat safely and consistently reduces albuminuria across a broad range of CKD stages and hypertension statuses, with numerically greater response rates when combined with empagliflozin.
Supports the broad efficacy of vicadrostat across diverse CKD and blood pressure profiles; extends the.
Introduction: analyses assessed the effects of vicadrostat, with or without background empagliflozin, on albuminuria across a range of CKD severity and hypertension (HTN) status. Methods: The analysis set included 503 participants who had urine albumin-to-creatinine ratio (UACR) measures available at baseline and week 14. Subgroup analyses of the effects of vicadrostat, given alone or with empagliflozin, were performed by the presence or absence of uncontrolled HTN (defined as blood pressure [BP] ≥ 140/90 mm Hg and use of ≥2 classes of antihypertensive medication), kidney failure risk equation (KFRE) 4-factor 5-year risk < 5% versus ≥ 5%, Kidney Disease: Improving Global Outcomes (KDIGO) moderate-to-high risk versus very high risk, and diuretic use at baseline. Results: UACR was reduced with vicadrostat, with or without empagliflozin background, across all subgroup analyses (adjusted mean reduction with 10 mg and 20 mg vicadrostat dose groups: 25%-55% vs. 24%-51% in the overall study). UACR reductions were consistent in participants irrespective of KDIGO risk group, KFRE subgroup, presence or absence of uncontrolled HTN at baseline or diuretic use. Conclusion: The effects of vicadrostat on albuminuria reduction, with or without empagliflozin, were generally consistent irrespective of CKD stage and kidney risk as scored using KDIGO or the KFRE, HTN status, or use of diuretics.
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Correa-Rotter et al. (2026) conducted an RCT in Chronic Kidney Disease (CKD) (n=503). Vicadrostat with or without empagliflozin vs. Placebo with or without empagliflozin was evaluated on Change from baseline in log-transformed urine albumin-to-creatinine ratio (UACR) at week 14 across subgroups. Vicadrostat, administered with or without empagliflozin, consistently reduced urine albumin-to-creatinine ratio by 25% to 55% across subgroups irrespective of CKD stage, kidney failure risk, hypertension status, or diuretic use.
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