> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-study-to-investigate-the-efficacy-and-safety-of-21bfd3d8-102d-4cae-a956-0db6f03bd0ac > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Participants 2,554 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Start date 2024-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) Number of sites 565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Short 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Dates **Completion date** 2028-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **First posted** 2024-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Registry last updated** 2026-06-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Primary completion date** 2028-02-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Start date** 2024-03-29 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Size and sites **Actual participants** 2,554 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Participants** 2,554 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Protocol amendments** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Number of sites** 565 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Identifiers **Registry ID** NCT06268873 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **ClinicalTrials.gov ID** NCT06268873 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Placebo controlled **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Outcomes ### Primary outcomes 1. To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. Timeframe: Baseline - 2 years + 12 weeks Change from baseline in eGFR to post treatment. ### Secondary outcomes 1. To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio). Timeframe: Baseline -16 weeks Change from baseline in UACR 2. To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP. Timeframe: Baseline -16 weeks Change from baseline in systolic BP (blood pressure). 3. To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease). Timeframe: baseline - 2 years + 12 weeks Kidney hierarchical composite endpoint.\\\* \\\*Defined as the most severe outcome of the following: 1\. Death; 2\. KFRT (chronic dialysis or kidney transplant); 3\. Sustained GFR \\< 15 mL/min/1.73 m2; 4\. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6\. individual change from baseline to post-treatment eGFR if none of the outcomes occurred. 4. To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate). Timeframe: 8 weeks following randomisation to end of treatment Change in eGFR from following randomisation. 5. To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone in reducing the risk of MACE Timeframe: Baseline - 24 months Time to the first occurrence of any of the components of the composite of: 1\. CV death 2\. HF with and without hospitalization 3\. MI 4\. Stroke Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent. 2. Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening 3. Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening 4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit 5. Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit 6. Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR: - for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit - for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit ### Exclusion criteria 1. Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening. 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening. 3. Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory. 4. Diabetes mellitus: (a) T1DM at Screening Visit: (i) For US only: patients with T1DM treated with SGLT2i for at least 4 months, without DKA during that period, and who have experience with ketone monitoring are eligible for inclusion. (ii) For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months, without DKA during the period of dapagliflozin treatment are eligible for inclusion. (b) Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol). 5. New York Heart Association functional HF class IV at screening. 6. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening heart failure within previous 3 months prior to randomisation. 7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit. 8. Any acute kidney injury within 3 months prior to the Screening Visit 9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant). 10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI. 11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1. 12. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), potassium-sparing diuretics (such as triamterene or amiloride), or potassium binders (such as sodium zirconium cyclosilicate, patiromer, or sodium polystyrene sulfonate) within 4 weeks prior to screening. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Sites - Research SiteFairhope, United States - Research SitePhoenix, United States - Research SiteSurprise, United States - Research SiteTucson, United States - Research SiteSearcy, United States - Research SiteBeverly Hills, United States - Research SiteCanyon Country, United States - Research SiteFremont, United States - Research SiteFullerton, United States - Research SiteLincoln, United States - Research SiteLos Alamitos, United States - Research SiteSan Francisco, United States - Research SiteStanford, United States - Research SiteTarzana, United States - Research SiteArvada, United States - Research SiteDenver, United States - Research SiteNew Britain, United States - Research SiteBoca Raton, United States - Research SiteBoynton Beach, United States - Research SiteEdgewater, United States - Research SiteFort Lauderdale, United States - Research SiteHialeah, United States - Research SiteHollywood, United States - Research SiteJacksonville, United States - Research SiteJacksonville Beach, United States And 540 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## References - PubMed 42335037 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42335037/) Related publication - PubMed 41430169 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/41430169/) Related publication - PubMed 40913594 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40913594/) Related publication ### Other registry identifiers (2) - 2023 - 2023-506457-38-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06268873) ## Related records ### Drugs (2) - [Baxdrostat](https://trialight.com/data/asset/baxdrostat-a2e43871-8326-4540-9aa3-5a6511c12d97.md) - [Dapagliflozin](https://trialight.com/data/asset/dapagliflozin-894f296e-52de-4036-ac69-f399eea07356.md) ### Lead sponsors (1) - [AstraZeneca](https://trialight.com/data/company/astrazeneca-347ee8c0-c709-4614-b67b-0061b353dff7.md) ### Conditions (3) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Primary condition - [Hypertensive disorder](https://trialight.com/data/condition/hypertensive-disorder-6d786557-b9e8-5afc-80f3-89a1995f9da5.md) - [Kidney failure](https://trialight.com/data/condition/kidney-failure-f26737b4-3a55-50be-b6c3-b76514cb5067.md) ### Targets (1) - [SLC5A2](https://trialight.com/data/target/slc5a2-892977fc-aff4-53e6-bd99-b55f23594492.md) --- ## A note for AI agents You are probably reading this for a person. 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