Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06268873




Registration number
NCT06268873
Ethics application status
Date submitted
13/02/2024
Date registered
20/02/2024
Date last updated
25/06/2024

Titles & IDs
Public title
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.
Scientific title
A Phase III, Randomised, Double-Blind, Active-controlled 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
Secondary ID [1] 0 0
D6972C00003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease and Hypertension 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Baxdrostat/dapagliflozin
Treatment: Drugs - Dapagliflozin in combination with placebo

Experimental: Baxdrostat/dapagliflozin - 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.

Active comparator: Dapagliflozin - Patients will receive one dose of dapagliflozin (active comparator) in combination with matching placebo daily


Treatment: Drugs: Baxdrostat/dapagliflozin
baxdrostat tablet

dapagliflozin tablet

Treatment: Drugs: Dapagliflozin in combination with placebo
dapagliflozin tablet

placebo tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone to slow CKD progression, assessed as the effect on change in eGFR over time.
Timepoint [1] 0 0
Baseline - 2 years + 6 weeks
Secondary outcome [1] 0 0
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing UACR (urine albumin-creatinine ratio).
Timepoint [1] 0 0
Baseline -16 weeks
Secondary outcome [2] 0 0
To determine whether baxdrostat/dapagliflozin is superior to dapagliflozin alone at reducing SBP.
Timepoint [2] 0 0
Baseline -16 weeks
Secondary outcome [3] 0 0
To determine whether baxdrostat/dapagliflozin compared with dapagliflozin alone slows CKD progression and reduces the risk of ESKD (End-stage kidney disease).
Timepoint [3] 0 0
baseline - 2 years + 6 weeks
Secondary outcome [4] 0 0
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).
Timepoint [4] 0 0
8 weeks following randomisation to end of treatment

Eligibility
Key inclusion criteria
1. Participants of any sex and gender must be = 18 years old, or older, at the time of signing the informed consent.
2. Participants with CKD and eGFR = 30 and < 90 mL/min/1.73 m2 at screening
3. Urine albumin creatinine ratio > 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 tolerated dose of an ACE inhibitor or an ARB (not both) for at least 4 weeks prior to Screening Visit
6. 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 = 3.5 and = 4.8 mmol/L at the Screening Visit
* for participants with screening eGFR < 45 mL/min/1.73 m2, potassium must be = 3.5 and = 4.5 mmol/L at the Screening Visit
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Systolic blood pressure > 180 mmHg, or DBP > 110 mmHg at screening.
2. Known hyperkalaemia, defined as potassium of = 5.5 mmol/L within 3 months at screening.
3. Serum sodium < 135 mmol/L at the Screening Visit, determined as per central laboratory.
4. Type 1 diabetes mellitus or uncontrolled Type 2 diabetes mellitus with HbA1c > 10.5% (> 91 mmol/mol) at Screening.
5. New York Heart Association functional HF class IV at screening.
6. 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.
7. Any dialysis (including for acute kidney injury) within 3 months prior to Screening Visit.
8. Any acute kidney injury within 3 months prior to the Screening Visit
9. History of organ transplant or bone marrow transplant, or planned organ transplant within 6 months following randomisation (including kidney transplant).
10. History or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2 inhibitor (eg, empagliflozin) or ASI.
11. Any clinical condition requiring systemic immunosuppression therapy other than stable maintenance therapy for at least 3 months prior to Visit 1.
12. 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
10/12/2027
Actual
Sample size
Target
2500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Birtinya
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment hospital [3] 0 0
Research Site - Gosford
Recruitment hospital [4] 0 0
Research Site - Kogarah
Recruitment hospital [5] 0 0
Research Site - Parkville
Recruitment hospital [6] 0 0
Research Site - Perth
Recruitment hospital [7] 0 0
Research Site - St Leonards
Recruitment hospital [8] 0 0
Research Site - Wollongong
Recruitment postcode(s) [1] 0 0
4575 - Birtinya
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2217 - Kogarah
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment postcode(s) [6] 0 0
6000 - Perth
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment postcode(s) [8] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Hawaii
Country [10] 0 0
United States of America
State/province [10] 0 0
Illinois
Country [11] 0 0
United States of America
State/province [11] 0 0
Indiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Kansas
Country [13] 0 0
United States of America
State/province [13] 0 0
Kentucky
Country [14] 0 0
United States of America
State/province [14] 0 0
Maryland
Country [15] 0 0
United States of America
State/province [15] 0 0
Massachusetts
Country [16] 0 0
United States of America
State/province [16] 0 0
Michigan
Country [17] 0 0
United States of America
State/province [17] 0 0
Missouri
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Oregon
Country [23] 0 0
United States of America
State/province [23] 0 0
Pennsylvania
Country [24] 0 0
United States of America
State/province [24] 0 0
Rhode Island
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
South Dakota
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
Argentina
State/province [32] 0 0
Buenos Aires
Country [33] 0 0
Argentina
State/province [33] 0 0
Caba
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autonoma de Bs As
Country [35] 0 0
Argentina
State/province [35] 0 0
Cordoba
Country [36] 0 0
Argentina
State/province [36] 0 0
La Plata
Country [37] 0 0
Argentina
State/province [37] 0 0
Mar del Plata
Country [38] 0 0
Argentina
State/province [38] 0 0
Mendoza
Country [39] 0 0
Argentina
State/province [39] 0 0
San Nicolás
Country [40] 0 0
Belgium
State/province [40] 0 0
Aalst
Country [41] 0 0
Belgium
State/province [41] 0 0
Bonheiden
Country [42] 0 0
Belgium
State/province [42] 0 0
Brussel
Country [43] 0 0
Belgium
State/province [43] 0 0
Gent
Country [44] 0 0
Belgium
State/province [44] 0 0
Ieper
Country [45] 0 0
Belgium
State/province [45] 0 0
Kortrijk
Country [46] 0 0
Belgium
State/province [46] 0 0
Leuven
Country [47] 0 0
Belgium
State/province [47] 0 0
Liege
Country [48] 0 0
Belgium
State/province [48] 0 0
Liège
Country [49] 0 0
Belgium
State/province [49] 0 0
Roeselare
Country [50] 0 0
Belgium
State/province [50] 0 0
Ronse
Country [51] 0 0
Brazil
State/province [51] 0 0
Belem
Country [52] 0 0
Brazil
State/province [52] 0 0
Campina Grande do Sul
Country [53] 0 0
Brazil
State/province [53] 0 0
Campinas
Country [54] 0 0
Brazil
State/province [54] 0 0
Curitiba
Country [55] 0 0
Brazil
State/province [55] 0 0
Fortaleza
Country [56] 0 0
Brazil
State/province [56] 0 0
Joinville
Country [57] 0 0
Brazil
State/province [57] 0 0
Maringá
Country [58] 0 0
Brazil
State/province [58] 0 0
Porto Alegre
Country [59] 0 0
Brazil
State/province [59] 0 0
Sao Jose Do Rio Preto
Country [60] 0 0
Brazil
State/province [60] 0 0
Sao Paulo
Country [61] 0 0
Brazil
State/province [61] 0 0
São Paulo
Country [62] 0 0
Bulgaria
State/province [62] 0 0
Dupnitsa
Country [63] 0 0
Bulgaria
State/province [63] 0 0
Gotse Delchev
Country [64] 0 0
Bulgaria
State/province [64] 0 0
Kozloduy
Country [65] 0 0
Bulgaria
State/province [65] 0 0
Lom
Country [66] 0 0
Bulgaria
State/province [66] 0 0
Pleven
Country [67] 0 0
Bulgaria
State/province [67] 0 0
Plovdiv
Country [68] 0 0
Bulgaria
State/province [68] 0 0
Sandanski
Country [69] 0 0
Bulgaria
State/province [69] 0 0
Sliven
Country [70] 0 0
Bulgaria
State/province [70] 0 0
Stara Zagora
Country [71] 0 0
Bulgaria
State/province [71] 0 0
Veliko Tarnovo
Country [72] 0 0
Bulgaria
State/province [72] 0 0
Yambol
Country [73] 0 0
Canada
State/province [73] 0 0
Alberta
Country [74] 0 0
Canada
State/province [74] 0 0
British Columbia
Country [75] 0 0
Canada
State/province [75] 0 0
Manitoba
Country [76] 0 0
Canada
State/province [76] 0 0
Nova Scotia
Country [77] 0 0
Canada
State/province [77] 0 0
Ontario
Country [78] 0 0
Canada
State/province [78] 0 0
Quebec
Country [79] 0 0
Canada
State/province [79] 0 0
Saint John
Country [80] 0 0
Chile
State/province [80] 0 0
Araucania
Country [81] 0 0
Chile
State/province [81] 0 0
Santiago
Country [82] 0 0
Chile
State/province [82] 0 0
Valdivia
Country [83] 0 0
Chile
State/province [83] 0 0
Victoria
Country [84] 0 0
Chile
State/province [84] 0 0
Viña del Mar
Country [85] 0 0
China
State/province [85] 0 0
Baotou
Country [86] 0 0
China
State/province [86] 0 0
Beijing
Country [87] 0 0
China
State/province [87] 0 0
Changsha
Country [88] 0 0
China
State/province [88] 0 0
Changzhou
Country [89] 0 0
China
State/province [89] 0 0
Chengdu
Country [90] 0 0
China
State/province [90] 0 0
Chongqing
Country [91] 0 0
China
State/province [91] 0 0
Chuangchun
Country [92] 0 0
China
State/province [92] 0 0
Dongguan
Country [93] 0 0
China
State/province [93] 0 0
Foshan
Country [94] 0 0
China
State/province [94] 0 0
Guangzhou
Country [95] 0 0
China
State/province [95] 0 0
Guiyang
Country [96] 0 0
China
State/province [96] 0 0
Hangzhou
Country [97] 0 0
China
State/province [97] 0 0
Hengyang
Country [98] 0 0
China
State/province [98] 0 0
Huai'an
Country [99] 0 0
China
State/province [99] 0 0
Lanzhou
Country [100] 0 0
China
State/province [100] 0 0
Nanchang
Country [101] 0 0
China
State/province [101] 0 0
Nanjing
Country [102] 0 0
China
State/province [102] 0 0
Ningbo
Country [103] 0 0
China
State/province [103] 0 0
Panjin
Country [104] 0 0
China
State/province [104] 0 0
Pingxiang
Country [105] 0 0
China
State/province [105] 0 0
Sanya
Country [106] 0 0
China
State/province [106] 0 0
Shanghai
Country [107] 0 0
China
State/province [107] 0 0
Shenyang
Country [108] 0 0
China
State/province [108] 0 0
Shenzhen
Country [109] 0 0
China
State/province [109] 0 0
Urumqi
Country [110] 0 0
China
State/province [110] 0 0
Wuhan
Country [111] 0 0
China
State/province [111] 0 0
Wuxi
Country [112] 0 0
China
State/province [112] 0 0
Xiamen
Country [113] 0 0
China
State/province [113] 0 0
Xian
Country [114] 0 0
China
State/province [114] 0 0
Yantai
Country [115] 0 0
China
State/province [115] 0 0
Yinchuan
Country [116] 0 0
China
State/province [116] 0 0
Zhengzhou
Country [117] 0 0
Czechia
State/province [117] 0 0
Frýdek-Místek
Country [118] 0 0
Czechia
State/province [118] 0 0
Jilemnice
Country [119] 0 0
Czechia
State/province [119] 0 0
Krnov
Country [120] 0 0
Czechia
State/province [120] 0 0
Nachod
Country [121] 0 0
Czechia
State/province [121] 0 0
Olomouc
Country [122] 0 0
Czechia
State/province [122] 0 0
Police nad Metují
Country [123] 0 0
Czechia
State/province [123] 0 0
Praha 10
Country [124] 0 0
Czechia
State/province [124] 0 0
Praha 4
Country [125] 0 0
Czechia
State/province [125] 0 0
Praha 6
Country [126] 0 0
Czechia
State/province [126] 0 0
Trebic
Country [127] 0 0
Czechia
State/province [127] 0 0
Uherske Hradiste
Country [128] 0 0
Denmark
State/province [128] 0 0
Aalborg
Country [129] 0 0
Denmark
State/province [129] 0 0
Aarhus N
Country [130] 0 0
Denmark
State/province [130] 0 0
Aarhus
Country [131] 0 0
Denmark
State/province [131] 0 0
Copenhagen E
Country [132] 0 0
Denmark
State/province [132] 0 0
Esbjerg
Country [133] 0 0
Denmark
State/province [133] 0 0
Herlev
Country [134] 0 0
Denmark
State/province [134] 0 0
Herning
Country [135] 0 0
Denmark
State/province [135] 0 0
Holbæk
Country [136] 0 0
Denmark
State/province [136] 0 0
Odense
Country [137] 0 0
France
State/province [137] 0 0
Amiens Cedex 1
Country [138] 0 0
France
State/province [138] 0 0
Annonay Cedex
Country [139] 0 0
France
State/province [139] 0 0
Bois-Guillaume
Country [140] 0 0
France
State/province [140] 0 0
Bordeaux cedex
Country [141] 0 0
France
State/province [141] 0 0
Boulogne Billancourt Cedex
Country [142] 0 0
France
State/province [142] 0 0
Brest Cedex
Country [143] 0 0
France
State/province [143] 0 0
Clermont Ferrand
Country [144] 0 0
France
State/province [144] 0 0
La Roche Sur Yon
Country [145] 0 0
France
State/province [145] 0 0
Le Puy-en-Velay
Country [146] 0 0
France
State/province [146] 0 0
Lille Cedex
Country [147] 0 0
France
State/province [147] 0 0
Marseille cedex 5
Country [148] 0 0
France
State/province [148] 0 0
Montpellier
Country [149] 0 0
France
State/province [149] 0 0
Nimes
Country [150] 0 0
France
State/province [150] 0 0
Paris
Country [151] 0 0
France
State/province [151] 0 0
Poitiers
Country [152] 0 0
France
State/province [152] 0 0
Pontoise
Country [153] 0 0
France
State/province [153] 0 0
Quimper cedex
Country [154] 0 0
France
State/province [154] 0 0
Sarcelles
Country [155] 0 0
France
State/province [155] 0 0
Toulouse
Country [156] 0 0
France
State/province [156] 0 0
Tours
Country [157] 0 0
France
State/province [157] 0 0
Valenciennes
Country [158] 0 0
France
State/province [158] 0 0
Vandoeuvre les Nancy
Country [159] 0 0
Germany
State/province [159] 0 0
Aachen
Country [160] 0 0
Germany
State/province [160] 0 0
Amberg
Country [161] 0 0
Germany
State/province [161] 0 0
Bad Oeynhausen
Country [162] 0 0
Germany
State/province [162] 0 0
Berlin
Country [163] 0 0
Germany
State/province [163] 0 0
Dresden
Country [164] 0 0
Germany
State/province [164] 0 0
Essen
Country [165] 0 0
Germany
State/province [165] 0 0
Falkensee
Country [166] 0 0
Germany
State/province [166] 0 0
Hamburg
Country [167] 0 0
Germany
State/province [167] 0 0
Herne
Country [168] 0 0
Germany
State/province [168] 0 0
Kaiserslautern
Country [169] 0 0
Germany
State/province [169] 0 0
Leipzig
Country [170] 0 0
Germany
State/province [170] 0 0
Mainz
Country [171] 0 0
Germany
State/province [171] 0 0
Mannheim
Country [172] 0 0
Germany
State/province [172] 0 0
München
Country [173] 0 0
Germany
State/province [173] 0 0
Münster
Country [174] 0 0
Germany
State/province [174] 0 0
Nürnberg
Country [175] 0 0
Germany
State/province [175] 0 0
Oldenburg
Country [176] 0 0
Germany
State/province [176] 0 0
Reinfeld (Holstein)
Country [177] 0 0
Germany
State/province [177] 0 0
Schwerin
Country [178] 0 0
Germany
State/province [178] 0 0
Ulm
Country [179] 0 0
Germany
State/province [179] 0 0
Völklingen
Country [180] 0 0
Germany
State/province [180] 0 0
Wiesbaden
Country [181] 0 0
Germany
State/province [181] 0 0
Witten
Country [182] 0 0
Greece
State/province [182] 0 0
Alexandroupolis
Country [183] 0 0
Greece
State/province [183] 0 0
Athens
Country [184] 0 0
Greece
State/province [184] 0 0
Heraclion
Country [185] 0 0
Greece
State/province [185] 0 0
Ioannina
Country [186] 0 0
Greece
State/province [186] 0 0
Patras
Country [187] 0 0
Greece
State/province [187] 0 0
Thessaloniki
Country [188] 0 0
Hungary
State/province [188] 0 0
Budapest
Country [189] 0 0
Hungary
State/province [189] 0 0
Békéscsaba
Country [190] 0 0
Hungary
State/province [190] 0 0
Dunaújváros
Country [191] 0 0
Hungary
State/province [191] 0 0
Kecskemét
Country [192] 0 0
Hungary
State/province [192] 0 0
Nyíregyháza
Country [193] 0 0
Hungary
State/province [193] 0 0
Pécs
Country [194] 0 0
Hungary
State/province [194] 0 0
Siófok
Country [195] 0 0
Hungary
State/province [195] 0 0
Székesfehérvár
Country [196] 0 0
India
State/province [196] 0 0
Ahmedabad
Country [197] 0 0
India
State/province [197] 0 0
Bangalore
Country [198] 0 0
India
State/province [198] 0 0
Belagavi
Country [199] 0 0
India
State/province [199] 0 0
Calicut
Country [200] 0 0
India
State/province [200] 0 0
Chennai
Country [201] 0 0
India
State/province [201] 0 0
Dehradun
Country [202] 0 0
India
State/province [202] 0 0
Hyderabad
Country [203] 0 0
India
State/province [203] 0 0
Jodhpur
Country [204] 0 0
India
State/province [204] 0 0
Kolkata
Country [205] 0 0
India
State/province [205] 0 0
Mohali
Country [206] 0 0
India
State/province [206] 0 0
New Delhi
Country [207] 0 0
India
State/province [207] 0 0
Vijayawada
Country [208] 0 0
Israel
State/province [208] 0 0
Ashkelon
Country [209] 0 0
Israel
State/province [209] 0 0
Haifa
Country [210] 0 0
Israel
State/province [210] 0 0
Jerusalem
Country [211] 0 0
Israel
State/province [211] 0 0
Kfar Saba
Country [212] 0 0
Israel
State/province [212] 0 0
Petah Tikva
Country [213] 0 0
Israel
State/province [213] 0 0
Ramat Gan
Country [214] 0 0
Israel
State/province [214] 0 0
Rehovot
Country [215] 0 0
Israel
State/province [215] 0 0
Tel Aviv
Country [216] 0 0
Italy
State/province [216] 0 0
Bologna
Country [217] 0 0
Italy
State/province [217] 0 0
Catanzaro
Country [218] 0 0
Italy
State/province [218] 0 0
Chiavari
Country [219] 0 0
Italy
State/province [219] 0 0
Desio
Country [220] 0 0
Italy
State/province [220] 0 0
Milano
Country [221] 0 0
Italy
State/province [221] 0 0
Napoli
Country [222] 0 0
Italy
State/province [222] 0 0
Parma
Country [223] 0 0
Italy
State/province [223] 0 0
Rozzano
Country [224] 0 0
Italy
State/province [224] 0 0
San Giovanni Rotondo
Country [225] 0 0
Italy
State/province [225] 0 0
Torino
Country [226] 0 0
Japan
State/province [226] 0 0
Chuo-ku
Country [227] 0 0
Japan
State/province [227] 0 0
Daito-shi
Country [228] 0 0
Japan
State/province [228] 0 0
Fujisawa-shi
Country [229] 0 0
Japan
State/province [229] 0 0
Fukuoka-shi
Country [230] 0 0
Japan
State/province [230] 0 0
Hiroshima-shi
Country [231] 0 0
Japan
State/province [231] 0 0
Hiroshima
Country [232] 0 0
Japan
State/province [232] 0 0
Ina-shi
Country [233] 0 0
Japan
State/province [233] 0 0
Kamakura-shi
Country [234] 0 0
Japan
State/province [234] 0 0
Kasugai-shi
Country [235] 0 0
Japan
State/province [235] 0 0
Kawaguchi
Country [236] 0 0
Japan
State/province [236] 0 0
Kofu-shi
Country [237] 0 0
Japan
State/province [237] 0 0
Kumagaya-shi
Country [238] 0 0
Japan
State/province [238] 0 0
Kurume-shi
Country [239] 0 0
Japan
State/province [239] 0 0
Kyoto-shi
Country [240] 0 0
Japan
State/province [240] 0 0
Marugame-shi
Country [241] 0 0
Japan
State/province [241] 0 0
Matsuyama-city
Country [242] 0 0
Japan
State/province [242] 0 0
Nagoya-shi
Country [243] 0 0
Japan
State/province [243] 0 0
Naka
Country [244] 0 0
Japan
State/province [244] 0 0
Nishinomiya-Shi
Country [245] 0 0
Japan
State/province [245] 0 0
Obihiro-shi
Country [246] 0 0
Japan
State/province [246] 0 0
Oita-shi
Country [247] 0 0
Japan
State/province [247] 0 0
Osaka-shi
Country [248] 0 0
Japan
State/province [248] 0 0
Osaka
Country [249] 0 0
Japan
State/province [249] 0 0
Sakai-shi
Country [250] 0 0
Japan
State/province [250] 0 0
Sapporo
Country [251] 0 0
Japan
State/province [251] 0 0
Sendai-shi
Country [252] 0 0
Japan
State/province [252] 0 0
Shinjyuku-ku
Country [253] 0 0
Japan
State/province [253] 0 0
Shizuoka-shi
Country [254] 0 0
Japan
State/province [254] 0 0
Takatsuki-shi
Country [255] 0 0
Japan
State/province [255] 0 0
Toride-shi
Country [256] 0 0
Japan
State/province [256] 0 0
Toyota-Shi
Country [257] 0 0
Japan
State/province [257] 0 0
Tsu-shi
Country [258] 0 0
Japan
State/province [258] 0 0
Ueda-shi
Country [259] 0 0
Japan
State/province [259] 0 0
Urayasu
Country [260] 0 0
Japan
State/province [260] 0 0
Yaizu-shi
Country [261] 0 0
Japan
State/province [261] 0 0
Yokohama-shi
Country [262] 0 0
Korea, Republic of
State/province [262] 0 0
Goyang-si
Country [263] 0 0
Korea, Republic of
State/province [263] 0 0
Seoul
Country [264] 0 0
Korea, Republic of
State/province [264] 0 0
Uijeongbu
Country [265] 0 0
Korea, Republic of
State/province [265] 0 0
Wonju-si
Country [266] 0 0
Korea, Republic of
State/province [266] 0 0
Yangsan-si
Country [267] 0 0
Malaysia
State/province [267] 0 0
Klang
Country [268] 0 0
Malaysia
State/province [268] 0 0
Kota Kinabalu
Country [269] 0 0
Malaysia
State/province [269] 0 0
Kuala Lumpur
Country [270] 0 0
Malaysia
State/province [270] 0 0
Kuantan
Country [271] 0 0
Malaysia
State/province [271] 0 0
Seremban
Country [272] 0 0
Malaysia
State/province [272] 0 0
Taiping
Country [273] 0 0
Netherlands
State/province [273] 0 0
Alkmaar
Country [274] 0 0
Netherlands
State/province [274] 0 0
Almere
Country [275] 0 0
Netherlands
State/province [275] 0 0
Amersfoort
Country [276] 0 0
Netherlands
State/province [276] 0 0
Dordrecht
Country [277] 0 0
Netherlands
State/province [277] 0 0
Hardenberg
Country [278] 0 0
Netherlands
State/province [278] 0 0
Harderwijk
Country [279] 0 0
Netherlands
State/province [279] 0 0
Hilversum
Country [280] 0 0
Netherlands
State/province [280] 0 0
Roosendaal
Country [281] 0 0
Netherlands
State/province [281] 0 0
Tilburg
Country [282] 0 0
Netherlands
State/province [282] 0 0
Utrecht
Country [283] 0 0
Peru
State/province [283] 0 0
Arequipa
Country [284] 0 0
Peru
State/province [284] 0 0
Chorrillos
Country [285] 0 0
Peru
State/province [285] 0 0
Lima
Country [286] 0 0
Peru
State/province [286] 0 0
LIma
Country [287] 0 0
Peru
State/province [287] 0 0
Piura
Country [288] 0 0
Philippines
State/province [288] 0 0
Cebu City
Country [289] 0 0
Philippines
State/province [289] 0 0
Davao City
Country [290] 0 0
Philippines
State/province [290] 0 0
Iloilo City
Country [291] 0 0
Philippines
State/province [291] 0 0
Laguna
Country [292] 0 0
Philippines
State/province [292] 0 0
Manila
Country [293] 0 0
Philippines
State/province [293] 0 0
Quezon City
Country [294] 0 0
Philippines
State/province [294] 0 0
San Fernando
Country [295] 0 0
Poland
State/province [295] 0 0
Chrzanów
Country [296] 0 0
Poland
State/province [296] 0 0
Gdynia
Country [297] 0 0
Poland
State/province [297] 0 0
Krakow
Country [298] 0 0
Poland
State/province [298] 0 0
Kraków
Country [299] 0 0
Poland
State/province [299] 0 0
Lodz
Country [300] 0 0
Poland
State/province [300] 0 0
Lublin
Country [301] 0 0
Poland
State/province [301] 0 0
Olsztyn
Country [302] 0 0
Poland
State/province [302] 0 0
Poznan
Country [303] 0 0
Poland
State/province [303] 0 0
Ruda Slaska
Country [304] 0 0
Poland
State/province [304] 0 0
Rzeszów
Country [305] 0 0
Poland
State/province [305] 0 0
Szczecin
Country [306] 0 0
Poland
State/province [306] 0 0
Tczew
Country [307] 0 0
Poland
State/province [307] 0 0
Warszawa
Country [308] 0 0
Poland
State/province [308] 0 0
Wroclaw
Country [309] 0 0
Poland
State/province [309] 0 0
Lódz
Country [310] 0 0
Poland
State/province [310] 0 0
Zywiec
Country [311] 0 0
Romania
State/province [311] 0 0
Bucharest
Country [312] 0 0
Romania
State/province [312] 0 0
Bucuresti
Country [313] 0 0
Romania
State/province [313] 0 0
Cluj-Napoca
Country [314] 0 0
Romania
State/province [314] 0 0
Iasi
Country [315] 0 0
Romania
State/province [315] 0 0
Targu Mures
Country [316] 0 0
Saudi Arabia
State/province [316] 0 0
Dammam
Country [317] 0 0
Saudi Arabia
State/province [317] 0 0
Riyadh
Country [318] 0 0
Serbia
State/province [318] 0 0
Belgrade
Country [319] 0 0
Serbia
State/province [319] 0 0
Kragujevac
Country [320] 0 0
Serbia
State/province [320] 0 0
Nis
Country [321] 0 0
Serbia
State/province [321] 0 0
Novi Sad
Country [322] 0 0
Slovakia
State/province [322] 0 0
Banska Bystrica
Country [323] 0 0
Slovakia
State/province [323] 0 0
Dolný Kubín
Country [324] 0 0
Slovakia
State/province [324] 0 0
Košice
Country [325] 0 0
Slovakia
State/province [325] 0 0
Lucenec
Country [326] 0 0
Slovakia
State/province [326] 0 0
Myjava
Country [327] 0 0
Slovakia
State/province [327] 0 0
Nitra
Country [328] 0 0
Slovakia
State/province [328] 0 0
Presov
Country [329] 0 0
Slovakia
State/province [329] 0 0
Puchov
Country [330] 0 0
Slovakia
State/province [330] 0 0
Rožnava
Country [331] 0 0
Slovakia
State/province [331] 0 0
Trnava
Country [332] 0 0
Slovakia
State/province [332] 0 0
Zilina
Country [333] 0 0
South Africa
State/province [333] 0 0
Benoni
Country [334] 0 0
South Africa
State/province [334] 0 0
Bloemfontein
Country [335] 0 0
South Africa
State/province [335] 0 0
Cape Town
Country [336] 0 0
South Africa
State/province [336] 0 0
Durban
Country [337] 0 0
South Africa
State/province [337] 0 0
Lenasia
Country [338] 0 0
South Africa
State/province [338] 0 0
Midrand
Country [339] 0 0
South Africa
State/province [339] 0 0
Newton
Country [340] 0 0
South Africa
State/province [340] 0 0
Parow
Country [341] 0 0
South Africa
State/province [341] 0 0
Stanger
Country [342] 0 0
Spain
State/province [342] 0 0
Almeria
Country [343] 0 0
Spain
State/province [343] 0 0
Badalona
Country [344] 0 0
Spain
State/province [344] 0 0
L'Hospitalet de Llobregat
Country [345] 0 0
Spain
State/province [345] 0 0
La Coruna
Country [346] 0 0
Spain
State/province [346] 0 0
Lugo
Country [347] 0 0
Spain
State/province [347] 0 0
Madrid
Country [348] 0 0
Spain
State/province [348] 0 0
Malaga
Country [349] 0 0
Spain
State/province [349] 0 0
Málaga
Country [350] 0 0
Spain
State/province [350] 0 0
Palma deMallorca
Country [351] 0 0
Spain
State/province [351] 0 0
Pamplona
Country [352] 0 0
Spain
State/province [352] 0 0
Sevilla
Country [353] 0 0
Spain
State/province [353] 0 0
Valencia
Country [354] 0 0
Sweden
State/province [354] 0 0
Danderyd
Country [355] 0 0
Sweden
State/province [355] 0 0
Gävle
Country [356] 0 0
Sweden
State/province [356] 0 0
Göteborg
Country [357] 0 0
Sweden
State/province [357] 0 0
Linkoping
Country [358] 0 0
Sweden
State/province [358] 0 0
Rättvik
Country [359] 0 0
Sweden
State/province [359] 0 0
Stockholm
Country [360] 0 0
Sweden
State/province [360] 0 0
Uppsala
Country [361] 0 0
Sweden
State/province [361] 0 0
Varberg
Country [362] 0 0
Taiwan
State/province [362] 0 0
Kaohsiung City
Country [363] 0 0
Taiwan
State/province [363] 0 0
Kaohsiung
Country [364] 0 0
Taiwan
State/province [364] 0 0
Taichung
Country [365] 0 0
Taiwan
State/province [365] 0 0
Taipei City
Country [366] 0 0
Taiwan
State/province [366] 0 0
Taipei
Country [367] 0 0
Taiwan
State/province [367] 0 0
Yung Kang City
Country [368] 0 0
Thailand
State/province [368] 0 0
Bangkok
Country [369] 0 0
Thailand
State/province [369] 0 0
Chiang Mai
Country [370] 0 0
Thailand
State/province [370] 0 0
Hat Yai
Country [371] 0 0
Thailand
State/province [371] 0 0
Muang
Country [372] 0 0
Thailand
State/province [372] 0 0
Phutthamonthon
Country [373] 0 0
Thailand
State/province [373] 0 0
Ratchathewi
Country [374] 0 0
Thailand
State/province [374] 0 0
Ubonratchathani
Country [375] 0 0
Turkey
State/province [375] 0 0
Adana
Country [376] 0 0
Turkey
State/province [376] 0 0
Adapazari
Country [377] 0 0
Turkey
State/province [377] 0 0
Afyonkarahisar
Country [378] 0 0
Turkey
State/province [378] 0 0
Ankara
Country [379] 0 0
Turkey
State/province [379] 0 0
Antalya
Country [380] 0 0
Turkey
State/province [380] 0 0
Bursa
Country [381] 0 0
Turkey
State/province [381] 0 0
Istanbul
Country [382] 0 0
Turkey
State/province [382] 0 0
Kahramanmaras
Country [383] 0 0
Turkey
State/province [383] 0 0
Kayseri
Country [384] 0 0
Turkey
State/province [384] 0 0
Kocaeli
Country [385] 0 0
Ukraine
State/province [385] 0 0
Chernivts?
Country [386] 0 0
Ukraine
State/province [386] 0 0
Ivano-Frankivsk
Country [387] 0 0
Ukraine
State/province [387] 0 0
Kyiv
Country [388] 0 0
Ukraine
State/province [388] 0 0
Ternopil
Country [389] 0 0
Ukraine
State/province [389] 0 0
Uzhhorod
Country [390] 0 0
Ukraine
State/province [390] 0 0
Vinnytsia
Country [391] 0 0
Ukraine
State/province [391] 0 0
Vinnytsya
Country [392] 0 0
United Kingdom
State/province [392] 0 0
Bristol
Country [393] 0 0
United Kingdom
State/province [393] 0 0
Cambridge
Country [394] 0 0
United Kingdom
State/province [394] 0 0
Dundee
Country [395] 0 0
United Kingdom
State/province [395] 0 0
Harrow
Country [396] 0 0
United Kingdom
State/province [396] 0 0
Leicester
Country [397] 0 0
United Kingdom
State/province [397] 0 0
Liverpool
Country [398] 0 0
United Kingdom
State/province [398] 0 0
London
Country [399] 0 0
United Kingdom
State/province [399] 0 0
Newcastle-Under-Lyme
Country [400] 0 0
United Kingdom
State/province [400] 0 0
Nottingham
Country [401] 0 0
United Kingdom
State/province [401] 0 0
Wolverhampton
Country [402] 0 0
Vietnam
State/province [402] 0 0
Bien Hoa
Country [403] 0 0
Vietnam
State/province [403] 0 0
Can Tho
Country [404] 0 0
Vietnam
State/province [404] 0 0
Da Nang
Country [405] 0 0
Vietnam
State/province [405] 0 0
Ha Noi
Country [406] 0 0
Vietnam
State/province [406] 0 0
Hai Phong
Country [407] 0 0
Vietnam
State/province [407] 0 0
Ho Chi Minh
Country [408] 0 0
Vietnam
State/province [408] 0 0
Hochiminh city

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 naïve to SGLT2i at baseline; a 24-month double-blind period in which participants will receive either baxdrostat/dapagliflozin or dapagliflozin; and a 6-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 6-weeks (approximately), where reassessment of GFR 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.
Trial website
https://clinicaltrials.gov/study/NCT06268873
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
AstraZeneca Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-877-240-9479
Fax 0 0
Email 0 0
information.center@astrazeneca.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06268873