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.

Study identifier:D6972C00003

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:2023-506457-38-00

Will Be Recruiting

Official Title

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

Medical condition

Chronic kidney disease and hypertension

Phase

Phase 3

Healthy volunteers

No

Study drug

Baxdrostat/dapagliflozin, Dapagliflozin in combination with placebo

Sex

All

Estimated Enrollment

2500

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 29 Mar 2024
Estimated Primary Completion Date: 10 Dec 2027
Estimated Study Completion Date: 10 Dec 2027

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Feb 2024 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

-

Inclusion and exclusion criteria