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慢性腎臓病の成人患者におけるバルシンレノン/ダパグリフロジンとダパグリフロジンの有効性、安全性および忍容性の比較

基本情報

NCT ID
NCT06350123
ステータス
完了
試験のフェーズ
第2相
試験タイプ
介入
目標被験者数
324
治験依頼者名
AstraZeneca

概要

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.

対象疾患

Chronic Kidney Disease

介入

Balcinrenone/dapagliflozin 15 mg/10 mg and matching placebo for dapagliflozin 10 mg(DRUG)
Balcinrenone/dapagliflozin 40 mg/10 mg and matching placebo for dapagliflozin 10 mg(DRUG)
Dapagliflozin 10 mg and matching placebo for balcinrenone/dapa gliflozin(DRUG)

依頼者(Sponsor)