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NCT06268873 · ClinicalTrials.gov registry record · Phase 3
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.
A Phase 3 study of Chronic Kidney Disease and Hypertension, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 2,554
- Enrollment target
- 20
- Study locations
NCT06268873 is a Phase 3 study of Chronic Kidney Disease and Hypertension that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 2,554 participants. The trial reports 20 study locations across 7 states.
The verdict
NCT06268873, a Phase 3 study of Chronic Kidney Disease and Hypertension, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,554 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Baxdrostat/dapagliflozin
- DRUG Dapagliflozin in combination with placebo
Study Locations (20)
California
- Research Site - Beverly Hills
- Research Site - Canyon Country
- Research Site - Fremont
- Research Site - Fullerton
- Research Site - Lincoln
- Research Site - Los Alamitos
- Research Site - San Francisco
- Research Site - Stanford
- Research Site - Tarzana
Arizona
- Research Site - Phoenix
- Research Site - Surprise
- Research Site - Tucson
Florida
- Research Site - Boca Raton
- Research Site - Boynton Beach
- Research Site - Edgewater
Colorado
- Research Site - Arvada
- Research Site - Denver
Alabama
- Research Site - Fairhope
Arkansas
- Research Site - Searcy
Connecticut
- Research Site - New Britain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,554 participants |
| Start Date | 2024-03-29 |
| Est. Completion | 2028-02-24 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06268873
The ClinicalTrials.gov registry entry for NCT06268873 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 2,554 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Kidney Disease and Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Baxdrostat/dapagliflozin is the first listed.
NCT06268873 reports 20 study locations spanning 7 distinct geographic areas - top geographies include California, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT06268873 about?
NCT06268873 is a clinical study titled "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.". 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...
What is the current status of trial NCT06268873?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 2,554 participants. The study started on 2024-03-29. Estimated completion is 2028-02-24.
What conditions does trial NCT06268873 study?
This clinical trial studies the following conditions: Chronic Kidney Disease and Hypertension.
What interventions are being tested in trial NCT06268873?
The interventions under investigation include: Baxdrostat/dapagliflozin (DRUG), Dapagliflozin in combination with placebo (DRUG).
Who is sponsoring clinical trial NCT06268873?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06268873 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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