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. (NCT06268873)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants โฅ 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.
Who can join: Review the eligibility criteria below.
Location: Research Site โ Fairhope, Alabama
Age range: 18 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (565 Sites)
Showing the first 25 of 565 sites.
- Research Site โ Fairhope, Alabama
- Research Site โ Phoenix, Arizona
- Research Site โ Surprise, Arizona
- Research Site โ Tucson, Arizona
- Research Site โ Searcy, Arkansas
- Research Site โ Beverly Hills, California
- Research Site โ Canyon Country, California
- Research Site โ Fremont, California
- Research Site โ Fullerton, California
- Research Site โ Lincoln, California
- Research Site โ Los Alamitos, California
- Research Site โ San Francisco, California
- Research Site โ Stanford, California
- Research Site โ Tarzana, California
- Research Site โ Arvada, Colorado
- Research Site โ Denver, Colorado
- Research Site โ New Britain, Connecticut
- Research Site โ Boca Raton, Florida
- Research Site โ Boynton Beach, Florida
- Research Site โ Edgewater, Florida
- Research Site โ Fort Lauderdale, Florida
- Research Site โ Hialeah, Florida
- Research Site โ Hollywood, Florida
- Research Site โ Jacksonville, Florida
- Research Site โ Jacksonville Beach, Florida
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Chronic Kidney Disease and Hypertension
- A Phase IIb Study to Evaluate the Effect of Dapagliflozin in Combination With Baxdrostat Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure. โ Surprise, Arizona
- A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure โ Fairhope, Alabama
Explore by condition: All Chronic Kidney Disease and Hypertension clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.