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.
Condition(s) studied
Investigational drug(s) / intervention(s)
Baxdrostat/dapagliflozin: baxdrostat tablet dapagliflozin tablet
Dapagliflozin in combination with placebo: dapagliflozin tablet placebo tablet
Study summary
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin 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 untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-week open-label period in which all participants will discontinue baxdrostat/placebo 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 baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 12-weeks (approximately), where reassessment of eGFR 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.
Eligibility
Primary outcome measure(s)
- To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. — Baseline - 2 years + 12 weeks
Change from baseline in eGFR to post treatment.
Trial sites (565)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Fairhope | Alabama | |
| Research Site | Phoenix | Arizona | |
| Research Site | Surprise | Arizona | |
| Research Site | Tucson | Arizona | |
| Research Site | Searcy | Arkansas | |
| Research Site | Beverly Hills | California | |
| Research Site | Canyon Country | California | |
| Research Site | Fremont | California | |
| Research Site | Fullerton | California | |
| Research Site | Lincoln | California | |
| Research Site | Los Alamitos | California | |
| Research Site | San Francisco | California | |
| Research Site | Stanford | California | |
| Research Site | Tarzana | California | |
| Research Site | Arvada | Colorado | |
| Research Site | Denver | Colorado | |
| Research Site | New Britain | Connecticut | |
| Research Site | Boca Raton | Florida | |
| Research Site | Boynton Beach | Florida | |
| Research Site | Edgewater | Florida | |
| Research Site | Fort Lauderdale | Florida | |
| Research Site | Hialeah | Florida | |
| Research Site | Hollywood | Florida | |
| Research Site | Jacksonville | Florida | |
| Research Site | Jacksonville Beach | Florida | |
| Research Site | Lake City | Florida | |
| Research Site | Lake Worth | Florida | |
| Research Site | Melbourne | Florida | |
| Research Site | Miami | Florida | |
| Research Site | Miami Lakes | Florida | |
| Research Site | New Port Richey | Florida | |
| Research Site | Ocoee | Florida | |
| Research Site | Orlando | Florida | |
| Research Site | Orlando | Florida | |
| Research Site | Port Charlotte | Florida | |
| Research Site | Port Orange | Florida | |
| Research Site | Riverview | Florida | |
| Research Site | Winter Haven | Florida | |
| Research Site | Atlanta | Georgia | |
| Research Site | Conyers | Georgia |
+ 525 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06268873 on ClinicalTrials.gov ↗ ← All trials in Spain