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NCT07222917PHASE2Recruiting

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.

AstraZeneca

Start Date

12/5/2025

Completion Date

5/24/2027

Summary

International, Multicenter and Double-Blind study. The purpose is to measure the effect of baxdrostat in combination with dapagliflozin compared with baxdrostat/placebo on albuminuria, as well as safety, in participants with chronic kidney disease and high blood pressure.

Detailed Description

This is a Phase IIb, randomised, multicentre, double-blind, parallel-group study aiming to determine the effect on albuminuria, as well as safety, of baxdrostat/dapagliflozin compared with baxdrostat/placebo, when given to participants with CKD and high blood pressure. Study population will include participants ≥ 18 years old with CKD. Participants with or without a diagnosis of T2DM and with or without an SGLT2i treatment at screening are eligible for the study. The study will include an optional pre-screening period, where participants will be assessed for at least one of the following parameters: eGFR, UACR, potassium, sodium, and BP. Participants who are being treated with SGLT2i at the time of the screening visit will complete a washout period After screening and initial confirmation of eligibility, participants will be randomised to receive either baxdrostat/dapagliflozin or baxdrostat/placebo. For randomisation there will be stratification and capping linked to T2DM status. The primary objective is to assess the effect of baxdrostat/dapagliflozin compared with baxdrostat/matching placebo on albuminuria, which will be evaluated by change from baseline in UACR. The end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally, whichever occurs last. A participant is considered to have completed the study if they have completed all periods of the study including the last scheduled procedure shown in the SoA.

Eligibility Criteria

Age Range: 18 years to No maximum

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 eGFR ≥ 30 and \< 90 mL/min/1.73 m2 at screening 3. Participants with UACR \> 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 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. 6. Participants with: 1. Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2. 2. Serum or plasma potassium ≥ 3.0 and ≤ 4.5 mmol/L if eGFR \< 45 mL/min/1.73 m2. 7. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Applicable to female participants. Exclusion Criteria: 1. Systolic blood pressure \> 180 mmHg, or diastolic blood pressure \> 110 mmHg at screening. 2. Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months before screening 3. Serum sodium \< 135 mmol/L at the Screening Visit (values obtained within 4 weeks prior to screening or at the Screening Visit). 4. Diabetes mellitus: 1. T1DM at the screening visit 2. Uncontrolled T2DM at screening: HbA1C \> 10.5% (\> 91 mmol/mol) 5. New York Heart Association functional HF class IV at screening 6. 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 7. 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. 8. Known severe hepatic impairment, defined as Child-Pugh Class C, based on records that confirm documented medical history. 9. Documented history of adrenal insufficiency. 10. Any dialysis (including for acute kidney injury) within 3 months prior to the screening 11. Any acute kidney injury within 3 months prior to the screening visit. 12. Prohibited concomitant medications

Interventions

DRUG

Baxdrostat/dapagliflozin

DRUG

Baxdrostat/Placebo

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Conditions

Chronic Kidney Disease and Hypertension

Locations

Research Site

Surprise, Arizona 85374

United States

Research Site

Hollywood, Florida 33021

United States

Research Site

Port Charlotte, Florida 33952

United States

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Port Orange, Florida 32127

United States

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Atlanta, Georgia 30344

United States

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Champaign, Illinois 61822

United States

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Wichita, Kansas 67214

United States

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Eatontown, New Jersey 07724

United States

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Greenville, North Carolina 27834

United States

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Jacksonville, North Carolina 28546

United States

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New Bern, North Carolina 28562

United States

Research Site

Columbus, Ohio 43215

United States

Research Site

Media, Pennsylvania 19063

United States

Research Site

East Providence, Rhode Island 02914

United States

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Arlington, Texas 76015

United States

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Pasadena, Texas 77504

United States

Research Site

San Antonio, Texas 78212

United States

Research Site

Woodbridge, Virginia 22192

United States

Research Site

Buenos Aires, C1060AAB

Argentina

Research Site

Ciudad de Buenos Aires, C1425AGC

Argentina

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Mar del Plata, 7600

Argentina

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Rosario, S2000CVD

Argentina

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San Nicolás, B2900DMH

Argentina

Research Site

Pernik, 2300

Bulgaria

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Plovdiv, 4004

Bulgaria

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Sofia, 1431

Bulgaria

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Sofia, 1680

Bulgaria

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Sofia, 1756

Bulgaria

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Sofia, 1756

Bulgaria

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Yambol, 8600

Bulgaria

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Courtice, Ontario L1E 2J5

Canada

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Etobicoke, Ontario M9W 6V1

Canada

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Stouffville, Ontario L4A1H2

Canada

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Waterloo, Ontario N2T 0C1

Canada

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Montreal, Quebec H4J 1C5

Canada

Research Site

Anyang-si, 14068

South Korea

Research Site

Cheonan-si, 31151

South Korea

Research Site

Goyang-si, 10380

South Korea

Research Site

Seoul, 04401

South Korea

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Badalona, 08916

Spain

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Pamplona, 31008

Spain

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Valencia, 46010

Spain

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Kaohsiung City, 80756

Taiwan

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Kaohsiung City, 83301

Taiwan

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New Taipei City, 235

Taiwan

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Taichung, 402

Taiwan

Research Site

Taichung, 433004

Taiwan

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Taipei, 10002

Taiwan

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Taipei, 110

Taiwan

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Taoyuan, 333

Taiwan

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Bangkoknoi, 10700

Thailand

Research Site

Changwat Sara Buri, 18000

Thailand

Research Site

Hat Yai, 90110

Thailand

Research Site

Muang, 50200

Thailand

Research Site

Ratchathewi, 10400

Thailand

Research Site

Adana, 01060

Turkey (Türkiye)

Research Site

Adapazarı, 54290

Turkey (Türkiye)

Research Site

Kahramanmaraş, 46040

Turkey (Türkiye)

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Kayseri, 38039

Turkey (Türkiye)

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Kocaeli, 41380

Turkey (Türkiye)

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Kyiv, 01601

Ukraine

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Kyiv, 02002

Ukraine

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Kyiv, 02091

Ukraine

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Kyiv, 03037

Ukraine

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Kyiv, 03049

Ukraine

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Kyiv, 04210

Ukraine

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Uzhhorod, 88018

Ukraine

Research Site

Vinnytsia, 21029

Ukraine

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Dundee, DD1 9SY

United Kingdom

Research Site

Liverpool, L9 7AL

United Kingdom

Research Site

London, E1 1FR

United Kingdom