Balcinrenone+Dapagliflozin

DRUG3 trials

Sponsors

AstraZeneca AB

Conditions

ChronicChronic HF and comorbid impairment of kidney function who had a recent HF event to evaluate the effect of balcinrenone/dapagliflozin versus dapagliflozin alone on HF events and cardiovascular (CV) deathChronic Kidney Disease and AlbuminuriaRenal Insufficiency

Phase 2

A Phase IIb, Multicentre, 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

CompletedCTIS2023-509709-63-00

AstraZeneca ABChronic Kidney Disease and Albuminuria

Start: 2024-07-30End: 2025-05-09Target: 85Updated: 2025-04-23

Phase 3

A Phase III, Randomised, Double-blind Study to Evaluate the Effect of Balcinrenone/Dapagliflozin, Compared with Dapagliflozin, on the Risk of Heart Failure Events and Cardiovascular Death in Patients with Heart Failure and Impaired Kidney Function

RecruitingCTIS2023-508162-15-00

AstraZeneca ABChronic HF and comorbid impairment of kidney function who had a recent HF event to evaluate the effect of balcinrenone/dapagliflozin versus dapagliflozin alone on HF events and cardiovascular (CV) death

Start: 2024-07-12Target: 1194Updated: 2026-01-20

A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared with Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease (Stage 3b and 4)

Not yet recruitingCTIS2026-526114-90-00

AstraZeneca ABChronic, Renal Insufficiency

Target: 305Updated: 2026-10-20

A Phase III, Randomised, Double-blind, Study to Evaluate the Effect of Balcinrenone/Dapagliflozin Compared with Dapagliflozin on Renal and Cardiovascular Outcomes in Patients with Chronic Kidney Disease (Stage 3b and 4)

Not yet recruitingCTIS2026-526114-90-00

AstraZeneca ABChronic, Renal Insufficiency

Target: 305Updated: 2026-10-20