[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-kidney-disease-and-hypertension\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-kidney-disease-and-hypertension":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100573164","phase-3-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-100573164",false,"NCT06742723","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","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","BaxDuo-Pacific","Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with (a) or (b):\n\n   a) eGFR 30-59 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 30 mg\u002Fg (3.39 mg\u002Fmmol) and \\\u003C 500 mg\u002Fg (56.5 mg\u002Fmmol) (central laboratory value only), or\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only).\n\n     (b) eGFR 60-75 mL\u002Fmin\u002F1.73 m² (local or central laboratory value) AND:\n   * UACR ≥ 500 mg\u002Fg (56.5 mg\u002Fmmol) ) and ≤ 5000 mg\u002Fg (565 mg\u002Fmmol) (local or central laboratory value), or\n   * UPCR ≥ 700 mg\u002Fg (79 mg\u002Fmmol) and ≤ 7000 mg\u002Fg (790 mg\u002Fmmol) (local laboratory value only)\n3. \\[obsolete\\]\n4. 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.\n5. Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol\u002FL if eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol\u002FL if eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2 (local or central laboratory values)\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic BP \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol\u002FL within 3 months at screening.\n3. Serum sodium \\\u003C 135 mmol\u002FL (central or local laboratory values obtained within 4 weeks prior to screening or at the Screening Visit).\n\n4\\. Participants with T1DM will be excluded, except:\n\n1. 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.\n2. 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.\n\n   5 Uncontrolled T2DM with HbA1c \\> 10.5% (\\> 91 mmol\u002Fmol) (central or local laboratory values obtained within 3 months prior to screening or at the Screening Visit).\n\n   6 New York Heart Association functional HF class IV at screening.\n\n   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.\n\n   8 Documented history of adrenal insufficiency.\n\n   9 Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.\n\n   10 Any acute kidney injury within 3 months prior to the Screening Visit.\n\n   11 History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).\n\n   12 Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 months prior to Visit 1).","ALL","18 Years",{"count":20,"type":21},5000,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","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",[27],"Chronic Kidney Disease and Hypertension",[29,30,31,32,33,34,35],"Chronic kidney disease","Hypertension","Blood pressure","Baxdrostat","Dapagliflozin","Event-Driven","Outcome","RECRUITING","2026-06-25",{"date":39,"type":40},"2026-06-26","ACTUAL",{"date":42,"type":40},"2025-03-03",{"date":44,"type":21},"2029-12-18",{"name":46,"class":47},"AstraZeneca","INDUSTRY",764,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100610079","phase-2-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-100610079","NCT07222917","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.","A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination With Dapagliflozin Compared With Baxdrostat on Albuminuria in Participants With Chronic Kidney Disease and High Blood Pressure.","BaxDuo-Baltic","Inclusion Criteria:\n\n1. Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.\n2. Participants with eGFR ≥ 30 and \\\u003C 90 mL\u002Fmin\u002F1.73 m2 at screening\n3. Participants with UACR \\> 200 mg\u002Fg (22.6 mg\u002Fmmol) and \\\u003C 5000 mg\u002Fg (565 mg\u002Fmmol) at screening\n4. Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit.\n5. Stable and maximum daily tolerated dose of either an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to the screening visit, if not medically contraindicated.\n6. Participants with:\n\n   1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol\u002FL if eGFR ≥ 45 mL\u002Fmin\u002F1.73 m2.\n   2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol\u002FL if eGFR \\\u003C 45 mL\u002Fmin\u002F1.73 m2.\n7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants.\n\nExclusion Criteria:\n\n1. Systolic blood pressure \\> 180 mmHg, or diastolic blood pressure \\> 110 mmHg at screening.\n2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol\u002FL within 3 months before screening\n3. Serum sodium \\\u003C 135 mmol\u002FL at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit).\n4. Diabetes mellitus:\n\n   1. T1DM at the screening visit\n   2. Uncontrolled T2DM at screening: HbA1C \\> 10.5% (\\> 91 mmol\u002Fmol)\n5. New York Heart Association functional HF class IV at screening\n6. Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), aldosterone synthase inhibitors, 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\n7. Stroke, transient ischaemic cerebral attack, valve implantation or valve replacement, carotid surgery, or carotid angioplasty, acute coronary syndrome, or hospitalisation for worsening HF within previous 3 months prior to randomisation.\n8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history.\n9. Documented history of adrenal insufficiency.\n10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening\n11. Any acute kidney injury within 3 months prior to the screening visit.\n12. Prohibited concomitant medications",{"count":58,"type":21},218,[60],"PHASE2","International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat\u002Fplacebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.",[27],[29,30,31,32,33],"2026-05-15",{"date":66,"type":40},"2026-05-18",{"date":68,"type":40},"2025-12-05",{"date":70,"type":21},"2027-05-24",{"name":46,"class":47},71]