Balcinrenone + Dapagliflozin for Chronic Kidney Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the efficacy, safety and tolerability of balcinrenone in fixed combination with dapagliflozin, compared with dapagliflozin, in patients with CKD Stage 3b and 4 (eGFR ≥ 15 to \< 45 mL/min/1.73 m2) administered orally once daily in addition to SoC.
This is a population with high unmet medical need and an increased risk of CKD progression, who are frequently excluded from interventional trials.
Are You a Good Fit for This Trial?
This trial is for adults with moderate to severe chronic kidney disease (CKD stage 3b or 4, eGFR between 15 and less than 45) who are at high risk of their kidney disease getting worse. Participants should be able to take oral medication daily.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either balcinrenone/dapagliflozin or dapagliflozin alone, administered once daily in addition to standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares a new combination pill (balcinrenone plus dapagliflozin) versus dapagliflozin alone, both taken once daily along with standard care, to see which works better and is safer for people with CKD stages 3b and 4.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patient receives once daily 1 capsule balcinrenone 15 mg and dapagliflozin 10 mg and 1 placebo tablet matching dapagliflozin.
Patient receives once daily 1 placebo capsule matching balcinrenone and dapagliflozin and 1 tablet dapagliflozin 10 mg.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
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