Study identifier:D6972C00003
ClinicalTrials.gov identifier:NCT06268873
EudraCT identifier:N/A
CTIS identifier:2023-506457-38-00
A Phase III, Randomised, Double-Blind, Active-controlled Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination with Dapagliflozin Compared with Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants with CKD and High Blood Pressure
Chronic kidney disease and hypertension
Phase 3
No
Baxdrostat/dapagliflozin, Dapagliflozin in combination with placebo
All
2500
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Baxdrostat/dapagliflozin Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. | Drug: Baxdrostat/dapagliflozin baxdrostat tablet dapagliflozin tablet Other Name: Baxdrostat CIN-107 |
Active Comparator: Dapagliflozin Patients will receive one dose of dapagliflozin (active comparator) in combination with matching placebo daily | Drug: Dapagliflozin in combination with placebo dapagliflozin tablet placebo tablet |