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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)
アストラゼネカ株式会社(INDUSTRY)