A Phase III, Randomised, Double-blind, Placebo-controlled, Event-driven Study to Assess the Efficacy, Safety and Tolerability of Baxdrostat in Combination With Dapagliflozin Compared With Dapagliflozin Alone on Renal Outcomes and Cardiovascular Mortality in Participants With Chronic Kidney Disease and High Blood Pressure

Status: Recruiting
Location: See all (704) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

International, Multicenter, Double-Blind, Placebo-Controlled and Event-driven study to assess efficacy, safety and Tolerability of Baxdrostat in combination with Dapagliflozin on renal outcomes and cardiovascular mortality in participants with chronic kidney disease and high blood pressure

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants of any sex and gender must be ≥ 18 years of age at the time of signing the informed consent.

• Participants with (a) or (b):

⁃ eGFR 30-59 mL/min/1.73 m² (local or central laboratory value) AND:

∙ UACR ≥ 30 mg/g (3.39 mg/mmol) and \< 500 mg/g (56.5 mg/mmol) (central laboratory value only), or

‣ UACR ≥ 500 mg/g (56.5 mg/mmol) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or

‣ UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only).

∙ (b) eGFR 60-75 mL/min/1.73 m² (local or central laboratory value) AND:

‣ UACR ≥ 500 mg/g (56.5 mg/mmol) ) and ≤ 5000 mg/g (565 mg/mmol) (local or central laboratory value), or

‣ UPCR ≥ 700 mg/g (79 mg/mmol) and ≤ 7000 mg/g (790 mg/mmol) (local laboratory value only)

• \[obsolete\]

• Participants with history of HTN and a SBP ≥ 130 mmHg (the most recent value within 4 weeks prior to screening or at the Screening Visit) and ≥ 120 mmHg at the Randomisation Visit.

• Stable and maximum tolerated dose of an ACEi or an ARB (not both) for at least 4 weeks prior to Screening Visit.

• Participants with:

⁃ Serum or plasma potassium ≥ 3.0 and ≤ 4.8 mmol/L if eGFR ≥ 45 mL/min/1.73 m2 (local or central

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Research Site
RECRUITING
Ōita
Research Site
RECRUITING
Ōme
Research Site
RECRUITING
Ōmihachiman
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Osaka
Research Site
WITHDRAWN
Osaka
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Osaka
Research Site
RECRUITING
Saga
Research Site
RECRUITING
Sapporo
Research Site
RECRUITING
Sapporo
Research Site
RECRUITING
Sapporo
Research Site
NOT_YET_RECRUITING
Sendai
Research Site
NOT_YET_RECRUITING
Sendai
Research Site
RECRUITING
Shibuya-ku
Research Site
RECRUITING
Tanabe-shi
Research Site
RECRUITING
Toyoake-shi
Research Site
RECRUITING
Toyohashi
Research Site
NOT_YET_RECRUITING
Tsu
Research Site
RECRUITING
Yaizu-shi
Research Site
RECRUITING
Yokohama
Research Site
RECRUITING
Yoshida-gun
Malaysia
Research Site
RECRUITING
Ampang
Research Site
RECRUITING
Cheras
Research Site
RECRUITING
Ipoh
Research Site
RECRUITING
Kajang
Research Site
RECRUITING
Kota Bharu
Research Site
RECRUITING
Kuala Lumpur
Research Site
RECRUITING
Seremban
Research Site
RECRUITING
Seri Manjung
Mexico
Research Site
NOT_YET_RECRUITING
Chihuahua City
Research Site
NOT_YET_RECRUITING
Cuauhtémoc
Research Site
NOT_YET_RECRUITING
D.f
Research Site
NOT_YET_RECRUITING
Durango
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Guadalajara
Research Site
NOT_YET_RECRUITING
Mazatlán
Research Site
NOT_YET_RECRUITING
Mazatlán
Research Site
NOT_YET_RECRUITING
Mérida
Research Site
NOT_YET_RECRUITING
San Luis Potosí City
Research Site
NOT_YET_RECRUITING
Veracruz
Research Site
NOT_YET_RECRUITING
Zapopan
Netherlands
Research Site
RECRUITING
Amersfoort
Research Site
NOT_YET_RECRUITING
Amsterdam
Research Site
RECRUITING
Dordrecht
Research Site
RECRUITING
Groningen
Research Site
RECRUITING
Hilversum
Research Site
NOT_YET_RECRUITING
Leiden
Research Site
RECRUITING
Maastricht
Research Site
RECRUITING
Nieuwegein
Research Site
RECRUITING
Zwolle
Peru
Research Site
NOT_YET_RECRUITING
Arequipa
Research Site
NOT_YET_RECRUITING
Bellavista
Research Site
NOT_YET_RECRUITING
Chorrillos
Research Site
NOT_YET_RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Piura
Philippines
Research Site
NOT_YET_RECRUITING
Cebu City
Research Site
RECRUITING
Davao City
Research Site
NOT_YET_RECRUITING
Iloilo City
Research Site
NOT_YET_RECRUITING
Laguna
Research Site
NOT_YET_RECRUITING
Manila
Research Site
NOT_YET_RECRUITING
Quezon City
Research Site
WITHDRAWN
Quezon City
Research Site
WITHDRAWN
San Fernando City
Poland
Research Site
RECRUITING
Bialystok
Research Site
RECRUITING
Gdynia
Research Site
RECRUITING
Gdynia
Research Site
RECRUITING
Gmina Świecie
Research Site
RECRUITING
Grodzisk Mazowiecki
Research Site
RECRUITING
Jasło
Research Site
RECRUITING
Katowice
Research Site
RECRUITING
Katowice
Research Site
RECRUITING
Katowice
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Krakow
Research Site
RECRUITING
Lodz
Research Site
RECRUITING
Lodz
Research Site
RECRUITING
Lublin
Research Site
WITHDRAWN
Piaseczno
Research Site
NOT_YET_RECRUITING
Poznan
Research Site
NOT_YET_RECRUITING
Poznan
Research Site
RECRUITING
Radom
Research Site
RECRUITING
Rzeszów
Research Site
NOT_YET_RECRUITING
Szczecin
Research Site
RECRUITING
Szczecin
Research Site
RECRUITING
Szczecin
Research Site
RECRUITING
Tczew
Research Site
RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
RECRUITING
Warsaw
Research Site
RECRUITING
Warsaw
Research Site
NOT_YET_RECRUITING
Warsaw
Research Site
RECRUITING
Warsaw
Research Site
RECRUITING
Wroclaw
Research Site
RECRUITING
Wroclaw
Research Site
RECRUITING
Żywiec
Republic of Korea
Research Site
NOT_YET_RECRUITING
Ansan-si
Research Site
RECRUITING
Anyang-si
Research Site
RECRUITING
Busan
Research Site
RECRUITING
Cheonan-si
Research Site
RECRUITING
Goyang-si
Research Site
RECRUITING
Gwangju
Research Site
RECRUITING
Seongnam-si
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Seoul
Research Site
RECRUITING
Wŏnju
Research Site
RECRUITING
Yangsan
Romania
Research Site
WITHDRAWN
Brasov
Research Site
RECRUITING
Bucharest
Research Site
NOT_YET_RECRUITING
Bucharest
Research Site
NOT_YET_RECRUITING
Bucharest
Research Site
RECRUITING
Bucharest
Research Site
RECRUITING
Cluj-napoca
Research Site
RECRUITING
Craiova
Research Site
NOT_YET_RECRUITING
Craiova
Research Site
RECRUITING
Oradea
Research Site
RECRUITING
Suceava
Research Site
RECRUITING
Timișoara
Saudi Arabia
Research Site
NOT_YET_RECRUITING
Al-ahsa
Research Site
RECRUITING
Dammam
Research Site
WITHDRAWN
Riyadh
Research Site
NOT_YET_RECRUITING
Riyadh
Research Site
NOT_YET_RECRUITING
Riyadh
Research Site
NOT_YET_RECRUITING
Riyadh
Research Site
NOT_YET_RECRUITING
Riyadh/mena
Serbia
Research Site
NOT_YET_RECRUITING
Belgrade
Research Site
RECRUITING
Belgrade
Research Site
RECRUITING
Belgrade
Research Site
NOT_YET_RECRUITING
Belgrade
Research Site
NOT_YET_RECRUITING
Kamenitz
Research Site
NOT_YET_RECRUITING
Kragujevac
Research Site
RECRUITING
Kragujevac
Research Site
RECRUITING
Niš
Research Site
WITHDRAWN
Novi Sad
Research Site
RECRUITING
Novi Sad
Singapore
Research Site
RECRUITING
Singapore
Research Site
RECRUITING
Singapore
Research Site
RECRUITING
Singapore
Research Site
RECRUITING
Singapore
Slovakia
Research Site
NOT_YET_RECRUITING
Košice
Research Site
WITHDRAWN
Kráľovský Chlmec
Research Site
RECRUITING
Myjava
Research Site
RECRUITING
Nitra
Research Site
RECRUITING
Prešov
Research Site
WITHDRAWN
Prešov
Research Site
RECRUITING
Púchov
Research Site
RECRUITING
Žilina
South Africa
Research Site
NOT_YET_RECRUITING
Bellville
Research Site
RECRUITING
Benoni
Research Site
WITHDRAWN
Bloemfontein
Research Site
NOT_YET_RECRUITING
Bloemfontein
Research Site
RECRUITING
Cape Town
Research Site
RECRUITING
Cape Town
Research Site
NOT_YET_RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Durban
Research Site
WITHDRAWN
Durban
Research Site
RECRUITING
Durban
Research Site
NOT_YET_RECRUITING
Extension 8, Lenasia
Research Site
RECRUITING
Lenasia
Research Site
RECRUITING
Midrand
Research Site
RECRUITING
Newton
Research Site
WITHDRAWN
Parow
Spain
Research Site
RECRUITING
A Coruña
Research Site
RECRUITING
Almería
Research Site
RECRUITING
Badalona
Research Site
RECRUITING
L'hospitalet De Llobregat
Research Site
RECRUITING
Majadahonda
Research Site
RECRUITING
Málaga
Research Site
RECRUITING
Palma Demallorca
Research Site
RECRUITING
Pamplona
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Seville
Research Site
RECRUITING
Valencia
Research Site
RECRUITING
Valencia
Sweden
Research Site
NOT_YET_RECRUITING
Danderyd
Research Site
NOT_YET_RECRUITING
Huddinge
Research Site
NOT_YET_RECRUITING
Karlstad
Research Site
RECRUITING
Linköping
Research Site
RECRUITING
Uppsala
Research Site
NOT_YET_RECRUITING
Vaxjo
Taiwan
Research Site
RECRUITING
New Taipei City
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taichung
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taipei
Research Site
RECRUITING
Taoyuan District
Research Site
RECRUITING
Yung Kang City
Thailand
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Banphaeo
Research Site
RECRUITING
Hat Yai
Research Site
RECRUITING
Khon Kaen
Research Site
RECRUITING
Mueang
Research Site
RECRUITING
Phutthamonthon
Research Site
RECRUITING
Ubonratchathani
Turkey
Research Site
RECRUITING
Adana
Research Site
RECRUITING
Adapazarı
Research Site
RECRUITING
Altındağ
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Antalya
Research Site
RECRUITING
Haliliye
Research Site
RECRUITING
Kahramanmaraş
Research Site
RECRUITING
Kayseri
Research Site
RECRUITING
Kocaeli
Research Site
RECRUITING
Şahinbey
Ukraine
Research Site
RECRUITING
Chernivtsі
Research Site
RECRUITING
Ivano-frankivsk
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Kyiv
Research Site
RECRUITING
Ternopil
Research Site
RECRUITING
Ternopil
Research Site
RECRUITING
Uzhhorod
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Vinnytsia
Research Site
RECRUITING
Vinnytsia
Research Site
TERMINATED
Zhytomyr
United Kingdom
Research Site
RECRUITING
Bradford
Research Site
RECRUITING
Bristol
Research Site
RECRUITING
Canterbury
Research Site
RECRUITING
Cardiff
Research Site
RECRUITING
Dundee
Research Site
RECRUITING
Glasgow
Research Site
RECRUITING
Hownslow
Research Site
RECRUITING
London
Research Site
RECRUITING
London
Research Site
RECRUITING
Salford
Research Site
WITHDRAWN
Southampton
Research Site
RECRUITING
Swansea
Viet Nam
Research Site
RECRUITING
Da Nang
Research Site
RECRUITING
Haiphong
Research Site
NOT_YET_RECRUITING
Hanoi
Research Site
RECRUITING
Ho Chi Minh City
Research Site
NOT_YET_RECRUITING
Ho Chi Minh City
Research Site
RECRUITING
Ho Chi Minh City
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-03-03
Estimated Completion Date: 2030-04-18
Participants
Target number of participants: 5000
Treatments
Experimental: Baxdrostat/dapagliflozin
Participants randomised to the baxdrostat/dapagliflozin arm will initially receive a lower dose of baxdrostat and standard dose dapagliflozin. For participants that meet the up-titration criteria, baxdrostat may be up-titrated to higher dose.
Placebo_comparator: Placebo/dapagliflozin
Patients will receive one dose of dapagliflozin comparator in combination with matching placebo daily.
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov