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.
Public ClinicalTrials.gov record NCT06268873. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomised, Double-Blind 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06268873
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,554 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 29, 2024 (Actual)
- Primary completion
- Feb 24, 2028 (Estimated)
- Completion
- Feb 24, 2028 (Estimated)
- Last update posted
- Jun 26, 2026
2024 – 2028
United States locations
- U.S. sites
- 114
- U.S. states
- 28
- U.S. cities
- 100
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Fairhope | Alabama | 36532 | — |
| Research Site | Phoenix | Arizona | 85016 | — |
| Research Site | Surprise | Arizona | 85374 | — |
| Research Site | Tucson | Arizona | 85710 | — |
| Research Site | Searcy | Arkansas | 72143 | — |
| Research Site | Beverly Hills | California | 90211 | — |
| Research Site | Canyon Country | California | 91351 | — |
| Research Site | Fremont | California | 94538 | — |
| Research Site | Fullerton | California | 92835 | — |
| Research Site | Lincoln | California | 95648 | — |
| Research Site | Los Alamitos | California | 90720 | — |
| Research Site | San Francisco | California | 94110 | — |
| Research Site | Stanford | California | 94305 | — |
| Research Site | Tarzana | California | 91356 | — |
| Research Site | Arvada | Colorado | 80002 | — |
| Research Site | Denver | Colorado | 80220 | — |
| Research Site | New Britain | Connecticut | 06051 | — |
| Research Site | Boca Raton | Florida | 33487 | — |
| Research Site | Boynton Beach | Florida | 33435 | — |
| Research Site | Edgewater | Florida | 32132 | — |
| Research Site | Fort Lauderdale | Florida | 33316 | — |
| Research Site | Hialeah | Florida | 33012 | — |
| Research Site | Hollywood | Florida | 33021 | — |
| Research Site | Jacksonville | Florida | 32204 | — |
| Research Site | Jacksonville Beach | Florida | 32250 | — |
| Research Site | Lake City | Florida | 32055 | — |
| Research Site | Lake Worth | Florida | 33467 | — |
| Research Site | Melbourne | Florida | 32901 | — |
| Research Site | Miami | Florida | 33165 | — |
| Research Site | Miami Lakes | Florida | 33014 | — |
| Research Site | New Port Richey | Florida | 34652 | — |
| Research Site | Ocoee | Florida | 34761 | — |
| Research Site | Orlando | Florida | 32806 | — |
| Research Site | Orlando | Florida | 32808 | — |
| Research Site | Port Charlotte | Florida | 33952 | — |
| Research Site | Port Orange | Florida | 32127 | — |
| Research Site | Riverview | Florida | 33578 | — |
| Research Site | Winter Haven | Florida | 33880 | — |
| Research Site | Atlanta | Georgia | 30344 | — |
| Research Site | Conyers | Georgia | 30094 | — |
| Research Site | Macon | Georgia | 31210 | — |
| Research Site | Champaign | Illinois | 61822 | — |
| Research Site | Hazel Crest | Illinois | 60429 | — |
| Research Site | Huntley | Illinois | 60142 | — |
| Research Site | Rockford | Illinois | 61107 | — |
| Research Site | Evansville | Indiana | 47714 | — |
| Research Site | Fort Wayne | Indiana | 46804 | — |
| Research Site | Hutchinson | Kansas | 67502 | — |
| Research Site | Wichita | Kansas | 67214 | — |
| Research Site | Bethesda | Maryland | 20889 | — |
| Research Site | Lanham | Maryland | 20706 | — |
| Research Site | Boston | Massachusetts | 02114 | — |
| Research Site | Boston | Massachusetts | 02115 | — |
| Research Site | New Bedford | Massachusetts | 02740 | — |
| Research Site | Detroit | Michigan | 48202 | — |
| Research Site | Pontiac | Michigan | 48341 | — |
| Research Site | Saint Joseph | Michigan | 49085 | — |
| Research Site | City of Saint Peters | Missouri | 63376 | — |
| Research Site | Kansas City | Missouri | 64111 | — |
| Research Site | Kansas City | Missouri | 64128 | — |
| Research Site | Kansas City | Missouri | 64151 | — |
| Research Site | St Louis | Missouri | 63136 | — |
| Research Site | Eatontown | New Jersey | 07724 | — |
| Research Site | Binghamton | New York | 13905 | — |
| Research Site | Manhasset | New York | 11030 | — |
| Research Site | Middletown | New York | 10940 | — |
| Research Site | New York | New York | 10016 | — |
| Research Site | Niagara Falls | New York | 14304 | — |
| Research Site | Orchard Park | New York | 14127 | — |
| Research Site | Rockville Centre | New York | 11570 | — |
| Research Site | Greenville | North Carolina | 27834 | — |
| Research Site | Jacksonville | North Carolina | 28546 | — |
| Research Site | New Bern | North Carolina | 28562 | — |
| Research Site | Statesville | North Carolina | 28625 | — |
| Research Site | Wilmington | North Carolina | 28401 | — |
| Research Site | Wilmington | North Carolina | 28412 | — |
| Research Site | Columbus | Ohio | 43213 | — |
| Research Site | Columbus | Ohio | 43215 | — |
| Research Site | Maumee | Ohio | 43537 | — |
| Research Site | Chester | Pennsylvania | 19013 | — |
| Research Site | Langhorne | Pennsylvania | 19047 | — |
| Research Site | Uniontown | Pennsylvania | 15401 | — |
| Research Site | East Providence | Rhode Island | 02914 | — |
| Research Site | East Providence | Rhode Island | 02915 | — |
| Research Site | Providence | Rhode Island | 02904 | — |
| Research Site | Charleston | South Carolina | 29414 | — |
| Research Site | Columbia | South Carolina | 29203 | — |
| Research Site | Sioux Falls | South Dakota | 57104 | — |
| Research Site | Chattanooga | Tennessee | 37421 | — |
| Research Site | Memphis | Tennessee | 38105 | — |
| Research Site | Memphis | Tennessee | 38115 | — |
| Research Site | Arlington | Texas | 76015 | — |
| Research Site | Austin | Texas | 78726 | — |
| Research Site | Austin | Texas | 78751 | — |
| Research Site | Dallas | Texas | 75230 | — |
| Research Site | Dallas | Texas | 75246 | — |
| Research Site | Houston | Texas | 77004 | — |
| Research Site | Houston | Texas | 77040 | — |
| Research Site | Houston | Texas | 77084 | — |
| Research Site | Houston | Texas | 77099 | — |
| Research Site | Humble | Texas | 77338 | — |
| Research Site | Lewisville | Texas | 75057 | — |
| Research Site | Odessa | Texas | 79761 | — |
| Research Site | Pasadena | Texas | 77504 | — |
| Research Site | San Antonio | Texas | 78212 | — |
| Research Site | San Antonio | Texas | 78231 | — |
| Research Site | Salt Lake City | Utah | 84132 | — |
| Research Site | South Salt Lake | Utah | 84115 | — |
| Research Site | Burlington | Vermont | 05401 | — |
| Research Site | Arlington | Virginia | 22205 | — |
| Research Site | Manassas | Virginia | 20110 | — |
| Research Site | Newport News | Virginia | 23606 | — |
| Research Site | Salem | Virginia | 24153 | — |
| Research Site | Woodbridge | Virginia | 22192 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 451 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06268873, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 26, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06268873 live on ClinicalTrials.gov.