Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy, Safety and Tolerability of Balcinrenone/Dapagliflozin Compared to Dapagliflozin in Adults With Chronic Kidney Disease
Sponsor: AstraZeneca
Summary
The purpose of the study is to evaluate the efficacy, safety and tolerability of balcinrenone/dapagliflozin compared with dapagliflozin alone on patients with chronic kidney disease (CKD) and albuminuria. This study will evaluate the effect of the balcinrenone/dapagliflozin on urinary albumin-to-creatinine ratio (UACR), compared with dapagliflozin in patients with CKD. This is a dose-finding study aiming to identify an optimal dose of balcinrenone/dapagliflozin for a future Phase III study in patients with CKD.
Official title: A Phase IIb, Multicenter, Randomised, Double-Blind, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Balcinrenone in Combination With Dapagliflozin Compared With Dapagliflozin in Patients With Chronic Kidney Disease and Albuminuria
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2024-05-01
Completion Date
2025-05-09
Last Updated
2026-06-26
Healthy Volunteers
No
Conditions
Interventions
Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 15 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg
1 capsule of balcinrenone/dapagliflozin 40 mg/10 mg and 1 tablet of matching placebo for dapagliflozin 10 mg once daily, oral use
Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin
1 tablet of dapagliflozin 10 mg and 1 capsule of matching placebo for balcinrenone/dapagliflozin once daily, oral use
Locations (92)
Research Site
Sheffield, Alabama, United States
Research Site
Glendale, California, United States
Research Site
Waterbury, Connecticut, United States
Research Site
Hialeah, Florida, United States
Research Site
Miami Lakes, Florida, United States
Research Site
Annapolis, Maryland, United States
Research Site
New Bern, North Carolina, United States
Research Site
El Paso, Texas, United States
Research Site
Houston, Texas, United States
Research Site
Houston, Texas, United States
Research Site
San Antonio, Texas, United States
Research Site
Ogden, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Salt Lake City, Utah, United States
Research Site
Norfolk, Virginia, United States
Research Site
Linz, Austria
Research Site
Sankt Pölten, Austria
Research Site
Vienna, Austria
Research Site
Vienna, Austria
Research Site
Vienna, Austria
Research Site
Vienna, Austria
Research Site
Wels, Austria
Research Site
Porto Alegre, Brazil
Research Site
São Paulo, Brazil
Research Site
São Paulo, Brazil
Research Site
São Paulo, Brazil
Research Site
São Paulo, Brazil
Research Site
Burgas, Bulgaria
Research Site
Dobrich, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Plovdiv, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
London, Ontario, Canada
Research Site
Waterloo, Ontario, Canada
Research Site
Montreal, Quebec, Canada
Research Site
Québec, Quebec, Canada
Research Site
Changchun, China
Research Site
Changzhou, China
Research Site
Shanghai, China
Research Site
Shanghai, China
Research Site
Tianjin, China
Research Site
Bari, Italy
Research Site
Bologna, Italy
Research Site
Genoa, Italy
Research Site
Pavia, Italy
Research Site
Ageo, Japan
Research Site
Fujisawa-shi, Japan
Research Site
Fukuoka, Japan
Research Site
Koga-shi, Japan
Research Site
Koshigaya-shi, Japan
Research Site
Kumamoto, Japan
Research Site
Nagasaki, Japan
Research Site
Nagoya, Japan
Research Site
Okinawa-shi, Japan
Research Site
Takamatsu, Japan
Research Site
Zentsuji-shi, Japan
Research Site
Ipoh, Malaysia
Research Site
Johor Bahru, Malaysia
Research Site
Kajang, Malaysia
Research Site
Kota Bharu, Malaysia
Research Site
Kuala Terengganu, Malaysia
Research Site
Bialystok, Poland
Research Site
Grodzisk Mazowiecki, Poland
Research Site
Leżajsk, Poland
Research Site
Szczecin, Poland
Research Site
Warsaw, Poland
Research Site
Żywiec, Poland
Research Site
Barcelona, Spain
Research Site
Barcelona, Spain
Research Site
Córdoba, Spain
Research Site
Palma de Mallorca, Spain
Research Site
Valencia, Spain
Research Site
Kaohsiung City, Taiwan
Research Site
New Taipei City, Taiwan
Research Site
Taichung, Taiwan
Research Site
Tainan, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Taipei, Taiwan
Research Site
Ankara, Turkey (Türkiye)
Research Site
Gaziantep, Turkey (Türkiye)
Research Site
Kahramanmaraş, Turkey (Türkiye)
Research Site
Kayseri, Turkey (Türkiye)
Research Site
Kocaeli, Turkey (Türkiye)
Research Site
Dundee, United Kingdom
Research Site
London, United Kingdom
Research Site
Newquay, United Kingdom
Research Site
Nottingham, United Kingdom
Research Site
Haiphong, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hochiminh City, Vietnam