Actively Recruiting
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.
Led by AstraZeneca · Updated on 2026-04-03
218
Participants Needed
71
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 must be 18 years or older at the time of consent
- eGFR between 30 and less than 90 mL/min/1.73 m2 at screening
- Urinary 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 at least 130 mmHg at screening and at least 120 mmHg at randomization
- Stable maximum daily tolerated dose of either an ACE inhibitor or an ARB (not both) 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 for clinical studies
You will not qualify if you...
- Systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg at screening
- Known hyperkalaemia with potassium 5.5 mmol/L or higher within 3 months before screening
- Serum sodium below 135 mmol/L at screening
- Type 1 diabetes at screening
- Uncontrolled type 2 diabetes with HbA1C over 10.5% (greater than 91 mmol/mol) 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
- Stroke, transient ischemic attack, valve implantation or replacement, carotid surgery or angioplasty, acute coronary syndrome, or hospitalization for worsening heart failure within 3 months before randomization
- Severe hepatic impairment (Child-Pugh Class C)
- History of adrenal insufficiency
- Any dialysis within 3 months prior to screening
- Any 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
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
Actively Recruiting
4
Research Site
Port Orange, Florida, United States, 32127
Actively Recruiting
5
Research Site
Atlanta, Georgia, United States, 30344
Actively Recruiting
6
Research Site
Champaign, Illinois, United States, 61822
Actively Recruiting
7
Research Site
Wichita, Kansas, United States, 67214
Actively Recruiting
8
Research Site
Eatontown, New Jersey, United States, 07724
Actively Recruiting
9
Research Site
Greenville, North Carolina, United States, 27834
Actively Recruiting
10
Research Site
Jacksonville, North Carolina, United States, 28546
Actively Recruiting
11
Research Site
New Bern, North Carolina, United States, 28562
Actively Recruiting
12
Research Site
Columbus, Ohio, United States, 43215
Actively Recruiting
13
Research Site
Media, Pennsylvania, United States, 19063
Actively Recruiting
14
Research Site
East Providence, Rhode Island, United States, 02914
Actively Recruiting
15
Research Site
Arlington, Texas, United States, 76015
Actively Recruiting
16
Research Site
Pasadena, Texas, United States, 77504
Actively Recruiting
17
Research Site
San Antonio, Texas, United States, 78212
Actively Recruiting
18
Research Site
Woodbridge, Virginia, United States, 22192
Actively Recruiting
19
Research Site
Buenos Aires, Argentina, C1060AAB
Withdrawn
20
Research Site
Ciudad de Buenos Aires, Argentina, C1425AGC
Not Yet Recruiting
21
Research Site
Mar del Plata, Argentina, 7600
Not Yet Recruiting
22
Research Site
Rosario, Argentina, S2000CVD
Not Yet Recruiting
23
Research Site
San Nicolás, Argentina, B2900DMH
Not Yet Recruiting
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
Not Yet Recruiting
30
Research Site
Yambol, Bulgaria, 8600
Not Yet Recruiting
31
Research Site
Courtice, Ontario, Canada, L1E 2J5
Actively Recruiting
32
Research Site
Etobicoke, Ontario, Canada, M9W 6V1
Actively Recruiting
33
Research Site
Stouffville, Ontario, Canada, L4A1H2
Actively Recruiting
34
Research Site
Waterloo, Ontario, Canada, N2T 0C1
Actively Recruiting
35
Research Site
Montreal, Quebec, Canada, H4J 1C5
Not Yet Recruiting
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
Actively Recruiting
45
Research Site
New Taipei City, Taiwan, 235
Actively Recruiting
46
Research Site
Taichung, Taiwan, 402
Actively Recruiting
47
Research Site
Taichung, Taiwan, 433004
Actively Recruiting
48
Research Site
Taipei, Taiwan, 10002
Actively Recruiting
49
Research Site
Taipei, Taiwan, 110
Actively Recruiting
50
Research Site
Taoyuan, Taiwan, 333
Actively Recruiting
51
Research Site
Bangkoknoi, Thailand, 10700
Actively Recruiting
52
Research Site
Changwat Sara Buri, Thailand, 18000
Not Yet Recruiting
53
Research Site
Hat Yai, Thailand, 90110
Actively Recruiting
54
Research Site
Muang, Thailand, 50200
Not Yet Recruiting
55
Research Site
Ratchathewi, Thailand, 10400
Not Yet Recruiting
56
Research Site
Adana, Turkey (Türkiye), 01060
Not Yet Recruiting
57
Research Site
Adapazarı, Turkey (Türkiye), 54290
Actively Recruiting
58
Research Site
Kahramanmaraş, Turkey (Türkiye), 46040
Actively Recruiting
59
Research Site
Kayseri, Turkey (Türkiye), 38039
Actively Recruiting
60
Research Site
Kocaeli, Turkey (Türkiye), 41380
Actively Recruiting
61
Research Site
Kyiv, Ukraine, 01601
Actively Recruiting
62
Research Site
Kyiv, Ukraine, 02002
Actively Recruiting
63
Research Site
Kyiv, Ukraine, 02091
Actively Recruiting
64
Research Site
Kyiv, Ukraine, 03037
Actively Recruiting
65
Research Site
Kyiv, Ukraine, 03049
Actively Recruiting
66
Research Site
Kyiv, Ukraine, 04210
Actively Recruiting
67
Research Site
Uzhhorod, Ukraine, 88018
Actively Recruiting
68
Research Site
Vinnytsia, Ukraine, 21029
Actively Recruiting
69
Research Site
Dundee, United Kingdom, DD1 9SY
Active, Not Recruiting
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
CONTACT
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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