Chronic Kidney Disease and HypertensionPhase 3NCT06268873

A Phase III Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin on CKD Progression in Participants With CKD and High Blood Pressure.

A Phase 3 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 565 sites in 38 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN. This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease and Hypertension
What is being tested?: Baxdrostat/dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,554 participants
Where: 565 sitesin 38 countries
Study dates: 29 Mar 2024to 24 Feb 2028
Phase: Phase 3
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
Central laboratory serum potassium must meet the following criteria at the Screening Visit, based on screening eGFR:
for participants with screening eGFR ≥ 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.8 mmol/L at the Screening Visit
for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be ≥ 3.0 and ≤ 4.5 mmol/L at the Screening Visit

Who cannot join

Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
Diabetes mellitus:
T1DM at Screening Visit: (i) 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.
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.

Show all 15Show fewer

Uncontrolled T2DM at screening: HbA1C > 10.5% (> 91 mmol/mol).
New York Heart Association functional HF class IV at screening.
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.
Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
Any acute kidney injury within 3 months prior to the Screening Visit
History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
Any use of mineralocorticoid receptor antagonists (such as spironolactone, eplerenone, or finerenone), 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.

Trial locations and contacts

565 sites in 38 countries.

Country

City, postcode or hospital

565 sites in 38 countries

United States114 sites

Research Site
Arlington, Texas, 76015
Research Site
Arlington, Virginia, 22205
Research Site
Arvada, Colorado, 80002
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Atlanta, Georgia, 30344
Research Site
Austin, Texas, 78726
Research Site
Austin, Texas, 78751
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Bethesda, Maryland, 20889
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Beverly Hills, California, 90211
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Binghamton, New York, 13905
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Boca Raton, Florida, 33487
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Boston, Massachusetts, 02114
Research Site
Boston, Massachusetts, 02115
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Boynton Beach, Florida, 33435
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Burlington, Vermont, 05401
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Canyon Country, California, 91351
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Champaign, Illinois, 61822
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Charleston, South Carolina, 29414
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Chattanooga, Tennessee, 37421
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Chester, Pennsylvania, 19013
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City of Saint Peters, Missouri, 63376
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Columbia, South Carolina, 29203
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Columbus, Ohio, 43213
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Columbus, Ohio, 43215
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Conyers, Georgia, 30094
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Dallas, Texas, 75230
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Dallas, Texas, 75246
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Denver, Colorado, 80220
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Detroit, Michigan, 48202
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East Providence, Rhode Island, 02914
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East Providence, Rhode Island, 02915
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Eatontown, New Jersey, 07724
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Edgewater, Florida, 32132
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Evansville, Indiana, 47714
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Fairhope, Alabama, 36532
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Fort Lauderdale, Florida, 33316
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Fort Wayne, Indiana, 46804
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Fremont, California, 94538
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Fullerton, California, 92835
Research Site
Greenville, North Carolina, 27834
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Hazel Crest, Illinois, 60429
Research Site
Hialeah, Florida, 33012
Research Site
Hollywood, Florida, 33021
Research Site
Houston, Texas, 77004
Research Site
Houston, Texas, 77040
Research Site
Houston, Texas, 77084
Research Site
Houston, Texas, 77099
Research Site
Humble, Texas, 77338
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Huntley, Illinois, 60142
Research Site
Hutchinson, Kansas, 67502
Research Site
Jacksonville, Florida, 32204
Research Site
Jacksonville, North Carolina, 28546
Research Site
Jacksonville Beach, Florida, 32250
Research Site
Kansas City, Missouri, 64111
Research Site
Kansas City, Missouri, 64128
Research Site
Kansas City, Missouri, 64151
Research Site
Lake City, Florida, 32055
Research Site
Lake Worth, Florida, 33467
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Langhorne, Pennsylvania, 19047
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Lanham, Maryland, 20706
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Lewisville, Texas, 75057
Research Site
Lincoln, California, 95648
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Los Alamitos, California, 90720
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Macon, Georgia, 31210
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Manassas, Virginia, 20110
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Manhasset, New York, 11030
Research Site
Maumee, Ohio, 43537
Research Site
Melbourne, Florida, 32901
Research Site
Memphis, Tennessee, 38105
Research Site
Memphis, Tennessee, 38115
Research Site
Miami, Florida, 33165
Research Site
Miami Lakes, Florida, 33014
Research Site
Middletown, New York, 10940
Research Site
New Bedford, Massachusetts, 02740
Research Site
New Bern, North Carolina, 28562
Research Site
New Britain, Connecticut, 06051
Research Site
New Port Richey, Florida, 34652
Research Site
New York, New York, 10016
Research Site
Newport News, Virginia, 23606
Research Site
Niagara Falls, New York, 14304
Research Site
Ocoee, Florida, 34761
Research Site
Odessa, Texas, 79761
Research Site
Orchard Park, New York, 14127
Research Site
Orlando, Florida, 32806
Research Site
Orlando, Florida, 32808
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Pasadena, Texas, 77504
Research Site
Phoenix, Arizona, 85016
Research Site
Pontiac, Michigan, 48341
Research Site
Port Charlotte, Florida, 33952
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Port Orange, Florida, 32127
Research Site
Providence, Rhode Island, 02904
Research Site
Riverview, Florida, 33578
Research Site
Rockford, Illinois, 61107
Research Site
Rockville Centre, New York, 11570
Research Site
Saint Joseph, Michigan, 49085
Research Site
Salem, Virginia, 24153
Research Site
Salt Lake City, Utah, 84132
Research Site
San Antonio, Texas, 78212
Research Site
San Antonio, Texas, 78231
Research Site
San Francisco, California, 94110
Research Site
Searcy, Arkansas, 72143
Research Site
Sioux Falls, South Dakota, 57104
Research Site
South Salt Lake, Utah, 84115
Research Site
St Louis, Missouri, 63136
Research Site
Stanford, California, 94305
Research Site
Statesville, North Carolina, 28625
Research Site
Surprise, Arizona, 85374
Research Site
Tarzana, California, 91356
Research Site
Tucson, Arizona, 85710
Research Site
Uniontown, Pennsylvania, 15401
Research Site
Wichita, Kansas, 67214
Research Site
Wilmington, North Carolina, 28401
Research Site
Wilmington, North Carolina, 28412
Research Site
Winter Haven, Florida, 33880
Research Site
Woodbridge, Virginia, 22192

Other trials in United States

China39 sites

Research Site
Baotou, 014010
Research Site
Beijing, 100029
Research Site
Beijing, 100034
Research Site
Beijing, 100035
Research Site
Beijing, 100191
Research Site
Beijing, 102218
Research Site
Changchun, 130041
Research Site
Changsha, 410013
Research Site
Changzhou, 272100
Research Site
Chengdu, 610072
Research Site
Chongqing, 402260
Research Site
Dongguan, 523009
Research Site
Foshan, 528000
Research Site
Guangzhou, 510630
Research Site
Guangzhou, 510800
Research Site
Guiyang, 550044
Research Site
Haikou, 570311
Research Site
Hangzhou, 310014
Research Site
Hengyang, 421001
Research Site
Huai'an, 223300
Research Site
Lanzhou, 730000
Research Site
Nanchang, 330008
Research Site
Nanjing, 210009
Research Site
Ningbo, 315010
Research Site
Panjin, 124009
Research Site
Pingxiang, 337055
Research Site
Sanya, 572000
Research Site
Shanghai, 200240
Research Site
Shenyang, 110004
Research Site
Shenzhen, 518036
Research Site
Ürümqi, 831118
Research Site
Wuhan, 430010
Research Site
Wuhan, 430060
Research Site
Wuxi, 214023
Research Site
Xi'an, 710061
Research Site
Xiamen, 361004
Research Site
Yantai, 264000
Research Site
Yinchuan, 750004
Research Site
Zhengzhou, 450052

Other trials in China

Japan39 sites

Research Site
Chūōku, 103-0002
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 103-0028
Research Site
Daito-shi, 574-0074
Research Site
Fujisawa-shi, 251-8550
Research Site
Fukuoka, 815-8555
Research Site
Hiroshima, 730-8518
Research Site
Hiroshima, 732-0057
Research Site
Ina-shi, 396-8555
Research Site
Kamakura-shi, 247-0056
Research Site
Kamakura-shi, 247-8533
Research Site
Kasugai-shi, 486-8510
Research Site
Kawaguchi, 332-0015
Research Site
Kofu, 400-8506
Research Site
Kumagaya-shi, 360-0197
Research Site
Kurume-shi, 830-0011
Research Site
Kyoto, 606-8507
Research Site
Marugame-shi, 763-8502
Research Site
Matsuyama, 790-0024
Research Site
Nagoya, 457-8511
Research Site
Naka, 311-0113
Research Site
Nishinomiya-Shi, 662-0918
Research Site
Obihiro-shi, 080-0848
Research Site
Ōita, 870-0033
Research Site
Osaka, 553-0003
Research Site
Sakaishi, 593-8304
Research Site
Sapporo, 064-8570
Research Site
Sendai, 980-8574
Research Site
Shinjyuku-ku, 160-0022
Research Site
Shizuoka, 421-0117
Research Site
Takatsuki-shi, 569-8686
Research Site
Toride-shi, 302-0022
Research Site
Toyota-Shi, 471-8513
Research Site
Tsu, 514-1101
Research Site
Tsu, 514-8507
Research Site
Ueda-shi, 386-8610
Research Site
Urayasu, 279-0001
Research Site
Yaizu-shi, 425-8505
Research Site
Yokohama, 236-0004

Other trials in Japan

Poland23 sites

Research Site
Chrzanów, 32-500
Research Site
Gdynia, 81-157
Research Site
Krakow, 30-688
Research Site
Krakow, 31-156
Research Site
Krakow, 31-261
Research Site
Krakow, 31-513
Research Site
Krakow, 31-801
Research Site
Lodz, 90-549
Research Site
Lodz, 91-211
Research Site
Lodz, 91-363
Research Site
Lodz, 92-213
Research Site
Lublin, 20-090
Research Site
Olsztyn, 10-165
Research Site
Poznan, 60-355
Research Site
Poznan, 61-848
Research Site
Rzeszów, 35-055
Research Site
Szczecin, 70-111
Research Site
Tczew, 83-110
Research Site
Warsaw, 03-291
Research Site
Wroclaw, 50-381
Research Site
Wroclaw, 53-114
Research Site
Wroclaw, 53-673
Research Site
Żywiec, 34-300

Other trials in Poland

France21 sites

Research Site
Amiens, 80054
Research Site
Annonay, 07103
Research Site
Bois-Guillaume, 76230
Research Site
Bordeaux, 33076
Research Site
Boulogne-Billancourt, 92104
Research Site
Brest, 29200
Research Site
Clermont-Ferrand, 63003
Research Site
La Roche-sur-Yon, 85925
Research Site
Le Puy-en-Velay, 43000
Research Site
Lille, 59037
Research Site
Marseille, 13385
Research Site
Nîmes, 30029
Research Site
Paris, 75015
Research Site
Paris, 75020
Research Site
Poitiers, 86021
Research Site
Quimper, 29000
Research Site
Sarcelles, 95200
Research Site
Toulouse, 31400
Research Site
Tours, 37000
Research Site
Valenciennes, 59300
Research Site
Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany21 sites

Research Site
Aachen, 52074
Research Site
Amberg, 92224
Research Site
Bad Oeynhausen, 32545
Research Site
Berlin, 12203
Research Site
Berlin, 13187
Research Site
Berlin, 13353
Research Site
Bochum, 44787
Research Site
Dresden, 1307
Research Site
Essen, 45355
Research Site
Falkensee, 14612
Research Site
Hamburg, 22607
Research Site
Herne, 44625
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Leipzig, 04179
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Mainz, 55131
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München, 81675
Research Site
Münster, 48145
Research Site
Nuremberg, 90443
Research Site
Oldenburg, 23758
Research Site
Reinfeld (Holstein), 23858
Research Site
Ulm, 89081
Research Site
Völklingen, 66333

Other trials in Germany

Canada19 sites

Research Site
Brampton, Ontario, L6S 0C6
Research Site
Concord, Ontario, L4K 4M2
Research Site
Edmonton, Alberta, T6G 2G3
Research Site
Halifax, Nova Scotia, B3H 1V7
Research Site
Laval, Quebec, H7T 2P5
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London, Ontario, N6A 5A5
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Montreal, Quebec, H2X 0A9
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Montreal, Quebec, H4J 1C5
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Oshawa, Ontario, L1G 2B9
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Québec, Quebec, G1R 2J6
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Saint John, E2L 4L2
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Sherbrooke, Quebec, J1H 5N4
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Stoney Creek, Ontario, L8J 3W2
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Sydney, Nova Scotia, B1P 1P3
Research Site
Toronto, Ontario, M4G 3E8
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Toronto, Ontario, M5C 2T2
Research Site
Vancouver, British Columbia, V5Y 3W2
Research Site
Waterloo, Ontario, N2T 0C1
Research Site
Winnipeg, Manitoba, R2V 3M3

Other trials in Canada

South Korea16 sites

Research Site
Ansan-si, 15355
Research Site
Anyang-si, 14068
Research Site
Busan, 49241
Research Site
Cheonan-si, 31151
Research Site
Daejeon, 301-723
Research Site
Goyang-si, 10380
Research Site
Gwangju, 61469
Research Site
Seoul, 03181
Research Site
Seoul, 03312
Research Site
Seoul, 03722
Research Site
Seoul, 04401
Research Site
Seoul, 06273
Research Site
Seoul, 07061
Research Site
Uijeongbu-si, 11765
Research Site
Wŏnju, 26426
Research Site
Yangsan, 50612

Other trials in South Korea

Brazil15 sites

Research Site
Belém, 66073-005
Research Site
Campina Grande do Sul, 83.430-000
Research Site
Campinas, 13060-080
Research Site
Campinas, 13060-904
Research Site
Curitiba, 80230-130
Research Site
Curitiba, 80440-020
Research Site
Fortaleza, 60175-047
Research Site
Joinville, 89227-680
Research Site
Maringá, 87060-040
Research Site
Porto Alegre, 90035-074
Research Site
Porto Alegre, 90160-093
Research Site
São José do Rio Preto, 15090-000
Research Site
São Paulo, 04012-180
Research Site
São Paulo, 04038-031
Research Site
São Paulo, 05403-9000

Other trials in Brazil

Ukraine14 sites

Research Site
Chernivtsі, 58002
Research Site
Ivano-Frankivsk, 76000
Research Site
Kyiv, 01601
Research Site
Kyiv, 02081
Research Site
Kyiv, 03037
Research Site
Kyiv, 03057
Research Site
Kyiv, 04050
Research Site
Ternopil, 46000
Research Site
Ternopil, 46001
Research Site
Uzhhorod, 88018
Research Site
Vinnytsia, 21001
Research Site
Vinnytsia, 21009
Research Site
Vinnytsia, 21018
Research Site
Vinnytsia, 21029

Other trials in Ukraine

Bulgaria13 sites

Research Site
Dupnitsa, 2600
Research Site
Gotse Delchev, 2900
Research Site
Kozloduy, 3320
Research Site
Lom, 3600
Research Site
Pleven, 5800
Research Site
Plovdiv, 4000
Research Site
Plovdiv, 4001
Research Site
Plovdiv, 4004
Research Site
Sandanski, 2800
Research Site
Sliven, 8800
Research Site
Stara Zagora, 6000
Research Site
Veliko Tarnovo, 5000
Research Site
Yambol, 8600

Other trials in Bulgaria

India13 sites

Research Site
Bangalore, 560 092
Research Site
Belagavi, 590010
Research Site
Calicut, 673 008
Research Site
Chennai, 600037
Research Site
Coimbatore, 641018
Research Site
Dehradun, 248001
Research Site
Hyderabad, 500038
Research Site
Kolkata, 700020
Research Site
Madurai, 625107
Research Site
New Delhi, 110017
Research Site
New Delhi, 110029
Research Site
Pune, 411013
Research Site
Vijayawada, 520 008

Other trials in India

United Kingdom13 sites

Research Site
Bristol, BS105NB
Research Site
Cambridge, CB2 0XY
Research Site
Dundee, DD1 9SY
Research Site
Glasgow, G51 4TF
Research Site
Harrow, HA3 7LT
Research Site
Hounslow, TW4 7NR
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Leicester, Le5 4PW
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Liverpool, L9 7AL
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London, EC1A 2BE
Research Site
London, SE5 9RJ
Research Site
Newcastle-under-Lyme, ST4 6QG
Research Site
Nottingham, NG5 1PB
Research Site
Wolverhampton, WV10 0QP

Other trials in United Kingdom

Argentina12 sites

Research Site
Buenos Aires, ARG 1425
Research Site
CABA, C1061
Research Site
CABA, C1120AAC
Research Site
Ciudad Autonoma de Bs As, C1013AAB
Research Site
Ciudad de Buenos Aires, C1019ABS
Research Site
Córdoba, X5006CBI
Research Site
La Plata, B1900AVG
Research Site
Lanus, 1824
Research Site
Mar del Plata, 7600
Research Site
Mar del Plata, B7600
Research Site
Mendoza, M5500
Research Site
San Nicolás, B2900DMH

Other trials in Argentina

Slovakia11 sites

Research Site
Banská Bystrica, 974 01
Research Site
Lučenec, 984 01
Research Site
Martin, 03659
Research Site
Myjava, 90701
Research Site
Nitra, 949 01
Research Site
Nitra, 949 11
Research Site
Prešov, 080 01
Research Site
Púchov, 020 01
Research Site
Rožňava, 048 01
Research Site
Trnava, 91708
Research Site
Žilina, 010 01

Other trials in Slovakia

Spain11 sites

Research Site
A Coruña, 15006
Research Site
Almería, 4009
Research Site
Badalona, 08916
Research Site
L'Hospitalet de Llobregat, 08907
Research Site
Lugo, 27004
Research Site
Madrid, 28040
Research Site
Málaga, 29010
Research Site
Palma deMallorca, 07010
Research Site
Pamplona, 31008
Research Site
Seville, 41950
Research Site
Valencia, 46010

Other trials in Spain

Taiwan11 sites

Research Site
Kaohsiung City, 80756
Research Site
Kaohsiung City, 81362
Research Site
New Taipei City, 220
Research Site
Taichung, 402
Research Site
Taichung, 40447
Research Site
Taichung, 433004
Research Site
Taipei, 10002
Research Site
Taipei, 110
Research Site
Taipei, 112
Research Site
Taoyuan, 33305
Research Site
Yung Kang City, 71044

Other trials in Taiwan

Belgium10 sites

Research Site
Aalst, 9300
Research Site
Bonheiden, 2820
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Ieper, 8900
Research Site
Kortrijk, 8500
Research Site
Leuven, 3000
Research Site
Liège, 4000
Research Site
Roeselare, 8800
Research Site
Ronse, 9600

Other trials in Belgium

Czechia10 sites

Research Site
Frýdek-Místek, 738 01
Research Site
Jilemnice, 514 01
Research Site
Krnov, 794 01
Research Site
Náchod, 547 01
Research Site
Olomouc, 772 00
Research Site
Police nad Metují, 549 54
Research Site
Prague, 104 00
Research Site
Prague, 140 00
Research Site
Prague, 160 00
Research Site
Třebíč, 674 01

Other trials in Czechia

Italy10 sites

Research Site
Bologna, 40138
Research Site
Catanzaro, 88100
Research Site
Chiavari, 16034
Research Site
Desio, 20832
Research Site
Milan, 20142
Research Site
Naples, 80131
Research Site
Parma, 43126
Research Site
Rozzano, 20089
Research Site
San Giovanni Rotondo, 71013
Research Site
Torino, 10126

Other trials in Italy

Turkey (Türkiye)10 sites

Research Site
Adana, 01060
Research Site
Adapazarı, 54100
Research Site
Afyonkarahisar, 03030
Research Site
Ankara, 06230
Research Site
Antalya, 07059
Research Site
Bursa, 16059
Research Site
Istanbul, 34890
Research Site
Kahramanmaraş, 46100
Research Site
Kayseri, 38039
Research Site
Kocaeli, 41380

Other trials in Turkey (Türkiye)

Hungary9 sites

Research Site
Békéscsaba, 5600
Research Site
Budapest, 1036
Research Site
Budapest, 1132
Research Site
Kecskemét, 6000
Research Site
Nyíregyháza, 4400
Research Site
Pécs, 7624
Research Site
Pécs, 7635
Research Site
Siófok, 8600
Research Site
Székesfehérvár, 8000

Other trials in Hungary

Romania9 sites

Research Site
Bucharest, 010731
Research Site
Bucharest, 014461
Research Site
Bucharest, 022328
Research Site
Bucharest, 040883
Research Site
Cluj-Napoca, 400347
Research Site
Iași, 700503
Research Site
Oradea, 410469
Research Site
Târgu Mureş, 540136
Research Site
Timișoara, 300723

Other trials in Romania

South Africa9 sites

Research Site
Benoni, 1501
Research Site
Cape Town, 7570
Research Site
Cape Town, 7925
Research Site
Durban, 4091
Research Site
KwaDukuza, 4450
Research Site
Lenasia, 1827
Research Site
Midrand, 1685
Research Site
Newton, 2113
Research Site
Parow, 7505

Other trials in South Africa

Australia8 sites

Research Site
Birtinya, 4575
Research Site
Clayton, 3168
Research Site
Darlinghurst, 2010
Research Site
Gosford, 2250
Research Site
Kogarah, 2217
Research Site
Perth, 6000
Research Site
St Leonards, 2065
Research Site
Wollongong, 2500

Other trials in Australia

Israel8 sites

Research Site
Ashkelon, 78278
Research Site
Haifa, 34362
Research Site
Jerusalem, 9372212
Research Site
Kfar Saba, 44410
Research Site
Petah Tikva, 49372
Research Site
Ramat Gan, 52621
Research Site
Rehovot, 76100
Research Site
Tel Aviv, 6423906

Other trials in Israel

Thailand8 sites

Research Site
Bangkok, 10330
Research Site
Bangkok, 10700
Research Site
Chiang Mai, 50200
Research Site
Hat Yai, 90110
Research Site
Muang, 40002
Research Site
Phutthamonthon, 73170
Research Site
Ratchathewi, 10400
Research Site
Ubonratchathani, 34000

Other trials in Thailand

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Netherlands7 sites

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About this study

Official title: A Phase III, Randomised, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.

This study consists of a screening, a 4-week dapagliflozin run-in period for participants untreated with SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or placebo/dapagliflozin; and approximately 12-week open-label period in which all participants will discontinue baxdrostat/placebo and receive dapagliflozin alone. Site visits will take place at 2-, 4-, 8-, and 16- weeks following randomisation. Thereafter visits will occur approximately every 4 months, until the 24-month visit at which time baxdrostat/placebo will be discontinued. Participants will continue open-label dapagliflozin for another 12-weeks (approximately), where reassessment of eGFR will occur for the primary efficacy endpoint.

In the event of premature discontinuation of blinded study intervention, participants will continue in the study and receive open-label dapagliflozin monotherapy, unless the participant meets dapagliflozin specific discontinuation criteria, in which case all study interventions will be discontinued.

Conditions: Chronic Kidney Disease and Hypertension
Being tested: Baxdrostat/dapagliflozin, Dapagliflozin in combination with placebo
Keywords: Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin
Medical subject headings: Renal Insufficiency, Chronic, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Baxdrostat/dapagliflozinDrug
Also called Baxdrostat CIN-107
baxdrostat tablet
dapagliflozin tablet
Dapagliflozin in combination with placeboDrug
dapagliflozin tablet
placebo tablet

Study groups in NCT06268873
Study group	Role	What they receive
Baxdrostat/dapagliflozin	Experimental	Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose. Receives: Drug: Baxdrostat/dapagliflozin
Dapagliflozin	Active comparator	Patients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily Receives: Drug: Dapagliflozin in combination with placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Change from baseline in eGFR to post treatment.
Measured: Baseline - 2 years + 12 weeks

Secondary outcomes (5)

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio).
Change from baseline in UACR
Measured: Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP.
Change from baseline in systolic BP (blood pressure).
Measured: Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).
Kidney hierarchical composite endpoint.*
*Defined as the most severe outcome of the following: 1. Death; 2. KFRT (chronic dialysis or kidney transplant); 3. Sustained GFR < 15 mL/min/1.73 m2; 4. Sustained GFR decline from baseline of ≥ 57%; 5 Sustained GFR decline from baseline of ≥ 50%; or 6. individual change from baseline to post-treatment eGFR if none of the outcomes occurred.
Measured: baseline - 2 years + 12 weeks
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate).
Change in eGFR from following randomisation.
Measured: 8 weeks following randomisation to end of treatment
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone in reducing the risk of MACE
Time to the first occurrence of any of the components of the composite of:
1. CV death
2. HF with and without hospitalization
3. MI
4. Stroke
Measured: Baseline - 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Mar 202424 Feb 2028

First posted20 Feb 2024
Study start29 Mar 2024
Primary completion24 Feb 2028 (estimated)
Study completion24 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney Disease and HypertensionStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,554 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06268873
Sponsor's protocol ID: D6972C00003
Other IDs: 2023-506457-38-00, 2023
Status last verified: Jun 2026
First submitted: 13 Feb 2024
Last updated: 26 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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.

Publications

Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
PubMed 42335037
Muhammad Daniyal S, Ajaz H, Riaz M, Murad Khatoon N, Aftab Z, Tauqir Gondal H, Gul I, Sarwar M, Batool F, Fahim SL, Noor A, Khalid A, Ashraf DA, Jabarkhil R. Combination therapy with mineralocorticoid receptor antagonists and SGLT2 inhibitors versus SGLT2 inhibitor monotherapy in chronic kidney disease: an updated meta-analysis of randomized controlled trials. BMC Nephrol. 2025 Dec 22;27(1):69. doi: 10.1186/s12882-025-04710-2.
PubMed 41430169
Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
PubMed 40913594

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
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RecruitingPhase 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
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Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
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Community Health Worker Nutrition Self-Management Support for Cardio-Kidney-Metabolic Health
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All Chronic Kidney Disease and Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-Blind Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Chronic Kidney Disease (CKD) Progression in Participants With CKD and High Blood Pressure
ClinicalTrials.gov ID: NCT06268873
Acronym / sponsor ID: D6972C00003
Conditions: Chronic Kidney Disease and Hypertension
Keywords: Chronic kidney disease, Hypertension, Blood pressure, Baxdrostat, Dapagliflozin
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 2,554 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 29 Mar 2024 (actual)
Primary completion: 24 Feb 2028 (estimated)
Study completion: 24 Feb 2028 (estimated)
First posted: 20 Feb 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to measure the efficacy and safety of baxdrostat/dapagliflozin in participants ≥ 18 years of age with CKD and HTN.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Baxdrostat/dapagliflozin	Experimental	Drug: Baxdrostat/dapagliflozinParticipants randomised to the baxdrostat/dapagliflozin arm will initially receive a dose of baxdrostat lower dose and dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Dapagliflozin	Active comparator	Drug: Dapagliflozin in combination with placeboPatients will receive one dose of dapagliflozin (active comparator) in combination with placebo matching baxdrostat daily

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants of any sex and gender must be ≥ 18 years old, or older, at the time of signing the informed consent.
Participants with CKD and eGFR ≥ 30 and < 90 mL/min/1.73 m2 at screening
Urine albumin creatinine ratio > 200 mg/g (22.6 mg/mmol) and < 5000 mg/g (565 mg/mmol) at screening
Participants with history of HTN and a SBP ≥ 130 mmHg at screening and ≥ 120 mmHg at the randomisation visit
Stable and maximum tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit

Key exclusion criteria (15 listed)

Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
Known hyperkalaemia, defined as potassium of ≥ 5.5 mmol/L within 3 months at screening.
Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
Diabetes mellitus:
New York Heart Association functional HF class IV at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Baxdrostat/dapagliflozinAlso: Baxdrostat CIN-107baxdrostat tablet dapagliflozin tablet	Drug	Baxdrostat/dapagliflozin
Dapagliflozin in combination with placebodapagliflozin tablet placebo tablet	Drug	Dapagliflozin

Primary outcome

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Time frame: Baseline - 2 years + 12 weeks
Change from baseline in eGFR to post treatment.

5 secondary outcomes

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio).
Time frame: Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP.
Time frame: Baseline -16 weeks
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).
Time frame: baseline - 2 years + 12 weeks
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows the rate of kidney function decline after the hemodynamically-mediated acute effect on GFR (Glomerular Filtration Rate).
Time frame: 8 weeks following randomisation to end of treatment
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone in reducing the risk of MACE
Time frame: Baseline - 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
Derived from this study: PubMed 42335037Yeung EK, Rangaswami J, Tuttle KR, Grams ME, Tangri N, Vaduganathan M, Neuen BL. A Framework for Risk-Based Implementation of Combination Therapy in CKD: Who, Why, When, and How? Clin J Am Soc Nephrol. 2026 Jun 23. doi: 10.2215/CJN.0000001158. Online ahead of print.
Derived from this study: PubMed 41430169Muhammad Daniyal S, Ajaz H, Riaz M, Murad Khatoon N, Aftab Z, Tauqir Gondal H, Gul I, Sarwar M, Batool F, Fahim SL, Noor A, Khalid A, Ashraf DA, Jabarkhil R. Combination therapy with mineralocorticoid receptor antagonists and SGLT2 inhibitors versus SGLT2 inhibitor monotherapy in chronic kidney disease: an updated meta-analysis of randomized controlled trials. BMC Nephrol. 2025 Dec 22;27(1):69. doi: 10.1186/s12882-025-04710-2.
Derived from this study: PubMed 40913594Dwyer JP, Maklad N, Vedin O, Monyak J, Myte R, Chertow GM, Heerspink HJL, Little DJ. Efficacy and Safety of Baxdrostat in Participants with CKD and Uncontrolled Hypertension: A Randomized, Double-Blind, Placebo-Controlled Trial. J Am Soc Nephrol. 2026 Feb 1;37(2):299-311. doi: 10.1681/ASN.0000000849. Epub 2025 Sep 6.
Individual participant dataSharing planned: Yes. 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.

Related trials for Chronic Kidney Disease and Hypertension

Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
RecruitingPhase 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
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
Not yet recruiting
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Hypertension (HTN), CKD - Chronic Kidney Disease
Enrolling by invitationEarly Phase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

565 sites in 38 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Baxdrostat/dapagliflozin in people with Chronic Kidney Disease and Hypertension, run by AstraZeneca at 565 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 565 sites in United States, China, Japan, Poland, France and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time. (time frame: Baseline - 2 years + 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06268873, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.