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Clinical Trials in India / NCT06742723
Recruiting 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

NCT06742723 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2025-03-03
Last updated
2026-08-26

Condition(s) studied

Chronic Kidney Disease and Hypertension

Investigational drug(s) / intervention(s)

Baxdrostat/dapagliflozinPlacebo/dapagliflozin

Baxdrostat/dapagliflozin: baxdrostat tablet dapagliflozin tablet

Placebo/dapagliflozin: dapagliflozin tablet placebo tablet

Study 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
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).

Primary outcome measure(s)

Trial sites (771)

FacilityCityRegionStatus
Research Site Fairhope Alabama Recruiting
Research Site Surprise Arizona Recruiting
Research Site Tucson Arizona Recruiting
Research Site Beverly Hills California Recruiting
Research Site Canoga Park California Withdrawn
Research Site Concord California Recruiting
Research Site Fremont California Recruiting
Research Site Fullerton California Recruiting
Research Site Inglewood California Withdrawn
Research Site Los Alamitos California Recruiting
Research Site Los Angeles California Recruiting
Research Site San Diego California Withdrawn
Research Site San Francisco California Withdrawn
Research Site Stanford California Recruiting
Research Site Tarzana California Recruiting
Research Site Arvada Colorado Recruiting
Research Site Denver Colorado Withdrawn
Research Site New Britain Connecticut Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site Boca Raton Florida Recruiting
Research Site Boynton Beach Florida Recruiting
Research Site Edgewater Florida Recruiting
Research Site Fort Lauderdale Florida Recruiting
Research Site Hollywood Florida Recruiting
Research Site Jacksonville Beach Florida Recruiting
Research Site Lake City Florida Recruiting
Research Site Lakeland Florida Recruiting
Research Site Melbourne Florida Recruiting
Research Site Miami Lakes Florida Suspended
Research Site Ocoee Florida Recruiting
Research Site Port Charlotte Florida Recruiting
Research Site Port Orange Florida Recruiting
Research Site Riverview Florida Recruiting
Research Site Atlanta Georgia Recruiting
Research Site Augusta Georgia Withdrawn
Research Site Austell Georgia Recruiting
Research Site Brunswick Georgia Recruiting
Research Site Conyers Georgia Recruiting
Research Site Decatur Georgia Recruiting
Research Site East Point Georgia Recruiting

+ 731 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06742723 on ClinicalTrials.gov ↗ ← All trials in India