Actively Recruiting
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
Led by AstraZeneca · Updated on 2026-05-18
218
Participants Needed
71
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of combining baxdrostat with dapagliflozin versus baxdrostat with a placebo on albuminuria in adults with chronic kidney disease (CKD) and high blood pressure. This Phase IIb, randomized, multicenter, double-blind study includes participants aged 18 and older, with or without type 2 diabetes and with or without prior SGLT2 inhibitor treatment. The goal is to understand how these treatments affect kidney function and safety in this population. Participants will be randomly assigned to receive either a daily dose of baxdrostat combined with dapagliflozin or baxdrostat with a placebo matching dapagliflozin. Before randomization, some participants may go through an optional pre-screening and a washout period if they are currently taking an SGLT2 inhibitor. The study includes stratification based on diabetes status to balance groups. Throughout the study, participants will undergo assessments including measurements of urine albumin-to-creatinine ratio (UACR) to evaluate changes in albuminuria from baseline over up to 12 weeks. Safety and other health parameters such as blood pressure, potassium, and sodium levels will also be monitored. Study completion is defined by finishing all scheduled procedures, and the study continues until the last participant completes their last visit globally.
CONDITIONS
Brief Title
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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants of any sex and gender must be 18 years or older at the time of signing consent
- eGFR between 30 and 90 mL/min/1.73 m2 at screening
- Urine albumin-to-creatinine ratio (UACR) greater than 200 mg/g and less than 5000 mg/g at screening
- History of hypertension with systolic blood pressure 130 mmHg or higher at screening and 120 mmHg or higher at randomisation
- Stable and maximum tolerated daily dose of either an ACE inhibitor or an ARB for at least 4 weeks prior to screening, if not medically contraindicated
- Serum or plasma potassium between 3.0 and 4.8 mmol/L if eGFR is 45 mL/min/1.73 m2 or higher
- Serum or plasma potassium between 3.0 and 4.5 mmol/L if eGFR is less than 45 mL/min/1.73 m2
- Female participants must use contraception consistent with local regulations during the study
You will not qualify if you...
- Systolic blood pressure higher than 180 mmHg or diastolic blood pressure higher than 110 mmHg at screening
- Known hyperkalaemia with potassium 5.5 mmol/L or higher within 3 months before screening
- Serum sodium less than 135 mmol/L at screening
- Type 1 diabetes mellitus at screening
- Uncontrolled type 2 diabetes with HbA1C greater than 10.5% at screening
- New York Heart Association functional heart failure class IV at screening
- Use of mineralocorticoid receptor antagonists, aldosterone synthase inhibitors, potassium-sparing diuretics, or potassium binders within 4 weeks prior to screening
- History of stroke, transient ischemic attack, valve surgery, carotid surgery, acute coronary syndrome, or hospitalization for worsening heart failure within 3 months prior to randomisation
- Severe liver impairment classified as Child-Pugh Class C
- Documented history of adrenal insufficiency
- Dialysis within 3 months prior to screening
- Acute kidney injury within 3 months prior to screening
- Use of prohibited concomitant medications
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive daily doses of baxdrostat combined with either dapagliflozin or placebo to evaluate the effect on albuminuria and safety.
Regular visits during treatment period
Trial Site Locations
Total: 71 locations
1
Research Site
Surprise, Arizona, United States, 85374
Actively Recruiting
2
Research Site
Hollywood, Florida, United States, 33021
Actively Recruiting
3
Research Site
Port Charlotte, Florida, United States, 33952
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4
Research Site
Port Orange, Florida, United States, 32127
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5
Research Site
Atlanta, Georgia, United States, 30344
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6
Research Site
Champaign, Illinois, United States, 61822
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7
Research Site
Wichita, Kansas, United States, 67214
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8
Research Site
Eatontown, New Jersey, United States, 07724
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9
Research Site
Greenville, North Carolina, United States, 27834
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10
Research Site
Jacksonville, North Carolina, United States, 28546
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11
Research Site
New Bern, North Carolina, United States, 28562
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12
Research Site
Columbus, Ohio, United States, 43215
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13
Research Site
Media, Pennsylvania, United States, 19063
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14
Research Site
East Providence, Rhode Island, United States, 02914
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15
Research Site
Arlington, Texas, United States, 76015
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16
Research Site
Pasadena, Texas, United States, 77504
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17
Research Site
San Antonio, Texas, United States, 78212
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18
Research Site
Woodbridge, Virginia, United States, 22192
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19
Research Site
Buenos Aires, Argentina, C1060AAB
Withdrawn
20
Research Site
Ciudad de Buenos Aires, Argentina, C1425AGC
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21
Research Site
Mar del Plata, Argentina, 7600
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22
Research Site
Rosario, Argentina, S2000CVD
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23
Research Site
San Nicolás, Argentina, B2900DMH
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24
Research Site
Pernik, Bulgaria, 2300
Withdrawn
25
Research Site
Plovdiv, Bulgaria, 4004
Withdrawn
26
Research Site
Sofia, Bulgaria, 1431
Withdrawn
27
Research Site
Sofia, Bulgaria, 1680
Withdrawn
28
Research Site
Sofia, Bulgaria, 1756
Withdrawn
29
Research Site
Sofia, Bulgaria, 1756
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30
Research Site
Yambol, Bulgaria, 8600
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31
Research Site
Courtice, Ontario, Canada, L1E 2J5
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32
Research Site
Etobicoke, Ontario, Canada, M9W 6V1
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33
Research Site
Stouffville, Ontario, Canada, L4A1H2
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34
Research Site
Waterloo, Ontario, Canada, N2T 0C1
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35
Research Site
Montreal, Quebec, Canada, H4J 1C5
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36
Research Site
Anyang-si, South Korea, 14068
Withdrawn
37
Research Site
Cheonan-si, South Korea, 31151
Withdrawn
38
Research Site
Goyang-si, South Korea, 10380
Withdrawn
39
Research Site
Seoul, South Korea, 04401
Withdrawn
40
Research Site
Badalona, Spain, 08916
Withdrawn
41
Research Site
Pamplona, Spain, 31008
Withdrawn
42
Research Site
Valencia, Spain, 46010
Withdrawn
43
Research Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
44
Research Site
Kaohsiung City, Taiwan, 83301
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45
Research Site
New Taipei City, Taiwan, 235
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46
Research Site
Taichung, Taiwan, 402
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47
Research Site
Taichung, Taiwan, 433004
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48
Research Site
Taipei, Taiwan, 10002
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49
Research Site
Taipei, Taiwan, 110
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50
Research Site
Taoyuan, Taiwan, 333
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51
Research Site
Bangkoknoi, Thailand, 10700
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52
Research Site
Changwat Sara Buri, Thailand, 18000
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53
Research Site
Hat Yai, Thailand, 90110
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54
Research Site
Muang, Thailand, 50200
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55
Research Site
Ratchathewi, Thailand, 10400
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56
Research Site
Adana, Turkey (Türkiye), 01060
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57
Research Site
Adapazarı, Turkey (Türkiye), 54290
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58
Research Site
Kahramanmaraş, Turkey (Türkiye), 46040
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59
Research Site
Kayseri, Turkey (Türkiye), 38039
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60
Research Site
Kocaeli, Turkey (Türkiye), 41380
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61
Research Site
Kyiv, Ukraine, 01601
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62
Research Site
Kyiv, Ukraine, 02002
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63
Research Site
Kyiv, Ukraine, 02091
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64
Research Site
Kyiv, Ukraine, 03037
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65
Research Site
Kyiv, Ukraine, 03049
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66
Research Site
Kyiv, Ukraine, 04210
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67
Research Site
Uzhhorod, Ukraine, 88018
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68
Research Site
Vinnytsia, Ukraine, 21029
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69
Research Site
Dundee, United Kingdom, DD1 9SY
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70
Research Site
Liverpool, United Kingdom, L9 7AL
Actively Recruiting
71
Research Site
London, United Kingdom, E1 1FR
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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