NCT07222917

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.

A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.

Detailed description

This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure. Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i treatment at screening are eligible for the study. The study will include an optional pre-screening period, where participants will be assessed for at least one of the following parameters: eGFR, UACR, potassium, sodium, and BP. Participants who are being treated with SGLT2i at the time of the screening visit will complete a washout period After screening and initial confirmation of eligibility, participants will be randomised to receive either baxdrostat/dapagliflozin or baxdrostat/placebo. For randomisation there will be stratification and capping linked to T2DM status. The primary objective is to assess the effect of baxdrostat/dapagliflozin compared with baxdrostat/matching placebo on albuminuria, which will be evaluated by change from baseline in UACR. The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally, whichever occurs last. A participant is considered to have completed the study if they have completed all periods of the study including the last scheduled procedure shown in the SoA.

Conditions

• Chronic Kidney Disease and Hypertension

Interventions

Type	Name	Description
DRUG	Baxdrostat/dapagliflozin	baxdrostat tablet dapagliflozin tablet
DRUG	Baxdrostat/Placebo	baxdrostat tablet placebo tablet

Timeline

• Start date: 2025-12-05
• Primary completion: 2027-05-24
• Completion: 2027-05-24
• First posted: 2025-10-30
• Last updated: 2026-04-03

Locations

71 sites across 11 countries: United States, Argentina, Bulgaria, Canada, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study