jRCT2031260364尚未招募不适用
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 or more 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. (BalanceD-CKD)
未提供0 个研究点目标入组 200 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age 18 years or more
- •Diagnosis of CKD and at least one of the following:
- •a. eGFR 15 or more to less than 45 mL/min/1.73 m2 AND: UACR 30 mg/g or more (central laboratory) or UACR 100 mg/g or more (local laboratory) or UPCR 200 mg/g or more (local laboratory).
- •b. eGFR 15 or more to less than 30 mL/min/1.73 m2 and UACR less than 30 mg/g (local or central laboratory UACR value).
- •Serum/plasma K+ 5.0 mmol/L or less
- •Maximum tolerated dose of an ACEi or an ARB, unless contraindicated or not tolerated. The dose should be stable for at least 4 weeks before screening.
排除标准
- •Recent (within 90 days prior to screening) or ongoing dialysis, or likely to require dialysis within 3 months following randomisation
- •UACR 5000 mg/g or more or UPCR 7000 mg/g or more at screening.
- •SBP more than 180 mmHg or DBP more than 110 mmHg at screening.
- •SBP less than 90 mmHg at screening.
- •HbA1c more than 9% at screening
- •T1DM (except: For Japan only: patients with T1DM treated with dapagliflozin 10 mg for at least 4 months prior to Screening, without DKA during the period of dapagliflozin treatment are eligible for inclusion.)
- •Autosomal dominant polycystic kidney disease.
- •Major cardiac or valvular surgery, acute coronary syndrome (myocardial infarction or unstable angina), stroke, transient ischaemic attack within 12 weeks prior to screening.
- •Severe hepatic impairment (Child-Pugh Class C).
- •Adrenal insufficiency.
- •Clinically significant acute kidney injury within 12 weeks prior to the screening.
- •New York Heart Association functional HF class IV at screening, or hospitalisation for heart failure within 4 weeks prior to screening.
- •Any clinical condition requiring systemic immunosuppression therapy other than maintenance therapy (stable for at least 3 m
- •onths) prior to screening.
- •Solid organ or bone marrow transplant or a plan for transplant within 6 months following randomisation.
- •Any use of the following medications and supplements: MRAs, Aldosterone analogues, Aldosterone synthase inhibitors, any use of potassium binders within 2 weeks prior to screening, strong or moderate inducers or inhibitors of CYP3A4 prohibited at least one week prior to randomisation
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