> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-iii-renal-outcomes-and-cardiovascular-mortality-c5f29ecd-a0cc-4264-97cc-549e6ce6e4bb > Record changed: 2026-10-13 # 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 NCT06742723 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Participants 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Lead sponsor AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Start date 2025-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) Number of sites 771 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Title and summary **Summary** International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Acronym** BaxDuo-Pacific Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Official title** A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Dates **Completion date** 2029-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **First posted** 2024-12-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Registry last updated** 2026-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Primary completion date** 2029-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Start date** 2025-03-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Size and sites **Participants** 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Planned participants** 5,000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Number of sites** 771 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Lead sponsor** AstraZeneca Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Identifiers **Registry ID** NCT06742723 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **ClinicalTrials.gov ID** NCT06742723 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## 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/NCT06742723) ## Outcomes ### Primary outcomes 1. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure, Heart Failure events(HF), or CV death. Timeframe: Up to 37 months Time to the first occurrence of any of the components of the composite of: Kidney disease progression \* ≥ 50% sustained decline in eGFR \* Onset of kidney failure: \* Sustained eGFR \\< 15 mL/min/1.73 m2 or \* Chronic dialysis treatment or \* Receiving a kidney transplant or \* Death with a renal primary cause (death due to kidney failure when dialysis is not given) CV events \* HF with or without hospitalisation \* CV death ### Secondary outcomes 1. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of ≥ 50% sustained decline in eGFR, kidney failure or CV death. Timeframe: Up to 37 months Time to the first occurrence of any of the components of the composite of: \* ≥ 50% sustained decline in eGFR \* Onset of kidney failure: \* Sustained eGFR \\< 15 mL/min/1.73 m2 or \* Chronic dialysis treatment or \* Receiving a kidney transplant or \* Death with a renal primary cause (death due to kidney failure when dialysis is not given) \* CV death 2. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of MACE (Major Adverse Cardiac Events). Timeframe: Up to 37 months Time to the first occurrence of any of the components of the composite of: CV (cardiovascular) death, HF (heart failure) with and without hospitalization, Myocardial Infraction, Stroke 3. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of CV (cardiovascular) death. Timeframe: Up to 37 months Time to the first occurrence of any of the components of the composite of CV (cardiovascular) death 4. To determine whether baxdrostat/dapagliflozin is superior to placebo/dapagliflozin in reducing the risk of the composite endpoint of all-cause death. Timeframe: Up to 37 months Time to the first occurrence of any of the components of the composite of all-cause death Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## 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 of age at the time of signing the informed consent. 2. Participants with (a) or (b): a) eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 30 mg/g (3.39 mg/mmol) and < 500 mg/g (56.5 mg/mmol) (central laboratory value only), or - UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only). (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND: - UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or - UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only) 3. \[obsolete\] 4. Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit. 5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit. 6. Participants with: 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central laboratory values) 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR < 45 mL/min/1.73 m2 (local or central laboratory values) ### Exclusion criteria 1. Systolic blood pressure > 180 mmHg, or diastolic BP > 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 (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit). 4\. Participants with T1DM will be excluded, except: 1. 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. 2. 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. 5 Uncontrolled T2DM with HbA1c > 10.5% (> 91 mmol/mol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit). 6 New York Heart Association functional HF class IV at screening. 7 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. 8 Documented history of adrenal insufficiency. 9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit. 10 Any acute kidney injury within 3 months prior to the Screening Visit. 11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant). 12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1). Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## Sites - Research SiteFairhope, United StatesRecruiting - Research SiteSurprise, United StatesRecruiting - Research SiteTucson, United StatesRecruiting - Research SiteBeverly Hills, United StatesRecruiting - Research SiteCanoga Park, United StatesWithdrawn - Research SiteConcord, United StatesRecruiting - Research SiteFremont, United StatesRecruiting - Research SiteFullerton, United StatesRecruiting - Research SiteInglewood, United StatesWithdrawn - Research SiteLos Alamitos, United StatesRecruiting - Research SiteLos Angeles, United StatesRecruiting - Research SiteSan Diego, United StatesWithdrawn - Research SiteSan Francisco, United StatesWithdrawn - Research SiteStanford, United StatesRecruiting - Research SiteTarzana, United StatesRecruiting - Research SiteArvada, United StatesRecruiting - Research SiteDenver, United StatesWithdrawn - Research SiteNew Britain, United StatesRecruiting - Research SiteWashington D.C., United StatesRecruiting - Research SiteBoca Raton, United StatesRecruiting - Research SiteBoynton Beach, United StatesRecruiting - Research SiteEdgewater, United StatesRecruiting - Research SiteFort Lauderdale, United StatesRecruiting - Research SiteHollywood, United StatesRecruiting - Research SiteJacksonville Beach, United StatesRecruiting And 746 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## References - PubMed 42335037 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/42335037/) Related publication - PubMed 40913594 Source: [pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/40913594/) Related publication ### Other registry identifiers (2) - 2023 - 2023-506460-14-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06742723) ## 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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