baxdrostat/dapagliflozin / AstraZeneca - LARVOL DELTA

BaxDuo-Baltic: A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. (clinicaltrials.gov) - P2 | N=222 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting | Trial completion date: May 2027 ➔ Dec 2026 | Trial primary completion date: May 2027 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

Baxdrostat/Dapagliflozin Chronic Kidney Disease Program: Design and Rationale (ERA 2026) - P2, P3 | "Conclusion Baxdrostat data generated to date suggest that baxdrostat improves BP control, reduces albuminuria, and has the potential to improve outcomes for patients living with CKD and HTN. Baxdrostat is being developed as a fixed-dose combination agent with dapagliflozin, and the baxdrostat/dapagliflozin CKD program is planned to randomise over 7700 participants globally to assess the efficacy and safety of baxdrostat/dapagliflozin for the treatment of CKD with HTN."

Cardiovascular • Chronic Kidney Disease • Congestive Heart Failure • Fibrosis • Heart Failure • Hypertension • Hypotension • Immunology • Inflammation • Nephrology • Renal Disease

D6972C00006: A Phase IIb study to evaluate the effect of combination of dapagliflozin and baxdrostat compared with baxdrostat alone in participants with chronic kidney disease and high blood pressure (clinicaltrialsregister.eu) - P1/2 | N=28 | Recruiting | Sponsor: AstraZeneca AB | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

BaxDuo-Baltic: A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. (clinicaltrials.gov) - P2 | N=218 | Recruiting | Sponsor: AstraZeneca | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

BaxDuo-Pacific: A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure (clinicaltrials.gov) - P3 | N=5000 | Recruiting | Sponsor: AstraZeneca | Trial completion date: Apr 2030 ➔ Dec 2029 | Trial primary completion date: Apr 2030 ➔ Dec 2029

Trial completion date • Trial primary completion date • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

BaxDuo-Baltic: A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: AstraZeneca

New P2 trial • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure. (clinicaltrials.gov) - P3 | N=2455 | Active, not recruiting | Sponsor: AstraZeneca | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Chronic Kidney Disease • Hypertension • Nephrology • Renal Disease