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. (BaxDuo-Baltic)

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease and Hypertension
• Intervention / Treatment: Drug: Baxdrostat/dapagliflozin; Drug: Baxdrostat/Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 218
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1060AAB
    • Withdrawn
    • Research Site
  • Ciudad de Buenos Aires, Argentina, C1425AGC
    • Recruiting
    • Research Site
  • Mar del Plata, Argentina, 7600
    • Recruiting
    • Research Site
  • Rosario, Argentina, S2000CVD
    • Recruiting
    • Research Site
  • San Nicolás, Argentina, B2900DMH
    • Recruiting
    • Research Site
• Bulgaria
  • Pernik, Bulgaria, 2300
    • Withdrawn
    • Research Site
  • Plovdiv, Bulgaria, 4004
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1756
    • Recruiting
    • Research Site
  • Sofia, Bulgaria, 1680
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1431
    • Withdrawn
    • Research Site
  • Sofia, Bulgaria, 1756
    • Withdrawn
    • Research Site
  • Yambol, Bulgaria, 8600
    • Recruiting
    • Research Site
• Canada
  • Ontario
    • Courtice, Ontario, Canada, L1E 2J5
      • Recruiting
      • Research Site
    • Etobicoke, Ontario, Canada, M9W 6V1
      • Recruiting
      • Research Site
    • Stouffville, Ontario, Canada, L4A1H2
      • Recruiting
      • Research Site
    • Waterloo, Ontario, Canada, N2T 0C1
      • Recruiting
      • Research Site
  • Quebec
    • Montreal, Quebec, Canada, H4J 1C5
      • Recruiting
      • Research Site
• South Korea
  • Anyang-si, South Korea, 14068
    • Withdrawn
    • Research Site
  • Cheonan-si, South Korea, 31151
    • Withdrawn
    • Research Site
  • Goyang-si, South Korea, 10380
    • Withdrawn
    • Research Site
  • Seoul, South Korea, 04401
    • Withdrawn
    • Research Site
• Spain
  • Badalona, Spain, 08916
    • Withdrawn
    • Research Site
  • Pamplona, Spain, 31008
    • Withdrawn
    • Research Site
  • Valencia, Spain, 46010
    • Withdrawn
    • Research Site
• Taiwan
  • Kaohsiung City, Taiwan, 80756
    • Recruiting
    • Research Site
  • Kaohsiung City, Taiwan, 83301
    • Recruiting
    • Research Site
  • New Taipei City, Taiwan, 235
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 402
    • Recruiting
    • Research Site
  • Taichung, Taiwan, 433004
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 10002
    • Recruiting
    • Research Site
  • Taipei, Taiwan, 110
    • Recruiting
    • Research Site
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Research Site
• Thailand
  • Bangkoknoi, Thailand, 10700
    • Recruiting
    • Research Site
  • Changwat Sara Buri, Thailand, 18000
    • Recruiting
    • Research Site
  • Hat Yai, Thailand, 90110
    • Recruiting
    • Research Site
  • Muang, Thailand, 50200
    • Recruiting
    • Research Site
  • Ratchathewi, Thailand, 10400
    • Recruiting
    • Research Site
• Turkey (Türkiye)
  • Adana, Turkey (Türkiye), 01060
    • Recruiting
    • Research Site
  • Adapazarı, Turkey (Türkiye), 54290
    • Recruiting
    • Research Site
  • Kahramanmaraş, Turkey (Türkiye), 46040
    • Recruiting
    • Research Site
  • Kayseri, Turkey (Türkiye), 38039
    • Recruiting
    • Research Site
  • Kocaeli, Turkey (Türkiye), 41380
    • Recruiting
    • Research Site
• Ukraine
  • Kyiv, Ukraine, 01601
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 02091
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 03037
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 04210
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 02002
    • Recruiting
    • Research Site
  • Kyiv, Ukraine, 03049
    • Recruiting
    • Research Site
  • Uzhhorod, Ukraine, 88018
    • Recruiting
    • Research Site
  • Vinnytsia, Ukraine, 21029
    • Recruiting
    • Research Site
• United Kingdom
  • Dundee, United Kingdom, DD1 9SY
    • Recruiting
    • Research Site
  • Liverpool, United Kingdom, L9 7AL
    • Recruiting
    • Research Site
  • London, United Kingdom, E1 1FR
    • Recruiting
    • Research Site
• United States
  • Arizona
    • Surprise, Arizona, United States, 85374
      • Recruiting
      • Research Site
  • Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Recruiting
      • Research Site
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30344
      • Recruiting
      • Research Site
  • Illinois
    • Champaign, Illinois, United States, 61822
      • Recruiting
      • Research Site
  • Kansas
    • Wichita, Kansas, United States, 67214
      • Recruiting
      • Research Site
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Recruiting
      • Research Site
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Recruiting
      • Research Site
    • Jacksonville, North Carolina, United States, 28546
      • Recruiting
      • Research Site
    • New Bern, North Carolina, United States, 28562
      • Recruiting
      • Research Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Recruiting
      • Research Site
  • Pennsylvania
    • Media, Pennsylvania, United States, 19063
      • Recruiting
      • Research Site
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Recruiting
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76015
      • Recruiting
      • Research Site
    • Pasadena, Texas, United States, 77504
      • Recruiting
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Research Site
  • Virginia
    • Woodbridge, Virginia, United States, 22192
      • Recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baxdrostat/dapagliflozin; Participants randomised to the baxdrostat/dapagliflozin arm will receive one dose of baxdrostat and one standard dose of dapagliflozin daily.	Drug: Baxdrostat/dapagliflozin; baxdrostat tablet dapagliflozin tablet
Placebo Comparator: Baxdrostat /placebo; Patients will receive one dose of baxdrostat comparator in combination with placebo matching dapagliflozin daily	Drug: Baxdrostat/Placebo; baxdrostat tablet placebo tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine whether baxdrostat/dapagliflozin is superior to baxdrostat/matching placebo at reducing albuminuria.	Change from baseline in UACR	Up to 12 weeks

Collaborators and Investigators

• Sponsor: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2025
• Primary Completion (Estimated): May 24, 2027
• Study Completion (Estimated): May 24, 2027

Study Registration Dates

• First Submitted: October 17, 2025
• First Submitted That Met QC Criteria: October 29, 2025
• First Posted (Actual): October 30, 2025

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Dapagliflozin; Hypertension; Blood pressure; Chronic kidney disease; Baxdrostat
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Hypertension; Renal Insufficiency, Chronic; dapagliflozin
• Other Study ID Numbers: D6972C00006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

"Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No