Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268873
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-02-13
Brief Title:
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
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to measure the efficacy and safety of baxdrostatdapagliflozin in participants 18 years of age with CKD and HTN This study consists of a screening a 4-week dapagliflozin run-in period for participants naïve to SGLT2i at baseline a 24-month double-blind period in which participants will receive either baxdrostatdapagliflozin or dapagliflozin and a 6-week open-label period in which all participants will discontinue baxdrostatplacebo and receive dapagliflozin alone
Site visits will take place at 2- 4- 8- and 16- weeks following randomisation Thereafter visits will occur approximately every 4 months until the 24-month visit at which time baxdrostatplacebo will be discontinued Participants will continue open-label dapagliflozin for another 6-weeks approximately where reassessment of GFR will occur for the primary efficacy endpoint In the event of premature discontinuation of blinded study intervention participants will continue in the study and receive open-label dapagliflozin monotherapy unless the participant meets dapagliflozin specific discontinuation criteria in which case all study interventions will be discontinued
Site visits will take place at 2- 4- 8- and 16- weeks following randomisation Thereafter visits will occur approximately every 4 months until the 24-month visit at which time baxdrostatplacebo will be discontinued Participants will continue open-label dapagliflozin for another 6-weeks approximately where reassessment of GFR will occur for the primary efficacy endpoint In the event of premature discontinuation of blinded study intervention participants will continue in the study and receive open-label dapagliflozin monotherapy unless the participant meets dapagliflozin specific discontinuation criteria in which case all study interventions will be discontinued
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None