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
Status: Recruiting
Location: See all (611) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:
• 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
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Romania
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Bucharest
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SUSPENDED
Bucharest
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Bucharest
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Bucharest
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Cluj-napoca
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Iași
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Oradea
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Târgu Mureş
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Timișoara
Saudi Arabia
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Dammam
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Riyadh
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Riyadh
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Riyadh
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Riyadh
Serbia
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Belgrade
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Belgrade
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Kragujevac
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Niš
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Novi Sad
Slovakia
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Banská Bystrica
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Dolný Kubín
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Košice
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Lučenec
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Martin
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Myjava
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Nitra
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Nitra
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Prešov
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Púchov
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Rožňava
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Trnava
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Žilina
South Africa
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Benoni
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Bloemfontein
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Cape Town
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Cape Town
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Durban
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Kwadukuza
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Lenasia
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Midrand
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Newton
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Parow
Spain
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A Coruña
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Almería
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Badalona
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L'hospitalet De Llobregat
Research Site
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Lugo
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Madrid
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Málaga
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WITHDRAWN
Málaga
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Palma Demallorca
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Pamplona
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Seville
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Valencia
Sweden
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Danderyd
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Gävle
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Gothenburg
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Linköping
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Rättvik
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Stockholm
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Uppsala
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Varberg
Taiwan
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Kaohsiung City
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Kaohsiung City
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New Taipei City
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Taichung
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Taichung
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Taichung
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Taipei
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Taipei
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Taipei
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Taoyuan District
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Yung Kang City
Thailand
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Bangkok
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Bangkok
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Muang
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Ratchathewi
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Ubonratchathani
Turkey
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Adana
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Adapazarı
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Afyonkarahisar
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Ankara
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Antalya
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Bursa
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Istanbul
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Kahramanmaraş
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Kayseri
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Kocaeli
Ukraine
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Chernivtsі
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Ivano-frankivsk
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Kyiv
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Ternopil
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Ternopil
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Uzhhorod
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Vinnytsia
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Vinnytsia
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Vinnytsia
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Vinnytsia
United Kingdom
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Bristol
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Cambridge
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Dundee
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Glasgow
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Harrow
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Hounslow
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Leicester
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Liverpool
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London
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London
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Newcastle-under-lyme
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Nottingham
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Wolverhampton
Viet Nam
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Biên Hòa
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Can Tho
Research Site
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Can Tho
Research Site
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Da Nang
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Hà Nội
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Haiphong
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Ho Chi Minh City
Research Site
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Ho Chi Minh City
Research Site
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Hochiminh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date:2024-03-29
Estimated Completion Date:2028-02-11
Participants
Target number of participants:2500
Treatments
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 placebo matching baxdrostat daily