Finerenone for Cardiorenal Protection in Diabetic CKD: Impact on Renal Function Decline and Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy
研究概览
简要总结
To assess the effect of Finerinone on slowing renal function decline and improving cardiovascular outcomes, particularly heart failure risk, in patients with diabetic CKD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Diagnosed cases of type 2 diabetes mellitus.
- •Chronic kidney disease with eGFR 25-90 mL/min/1.73m² and/or UACR ≥30 mg/g.
- •On stable ACE inhibitor or ARB therapy for at least 4 weeks.
- •Serum potassium ≤4.8 mmol/L.
- •Provided written informed consent.
排除标准
- •Symptomatic heart failure (NYHA class II-IV).
- •eGFR <25 mL/min/1.73m² or on maintenance dialysis.
- •Known non-diabetic kidney disease.
- •Recent major cardiovascular event (within 30 days).
- •Serum potassium >4.8 mmol/L or history of severe hyperkalaemia.
- •Contraindication or hypersensitivity to finerenone.
- •Pregnancy or lactation.
- •Any condition limiting compliance or follow-up.
研究组 & 干预措施
Finerenone Group
Finerenone Drug
干预措施: Finerenone (Drug)
结局指标
主要结局
Number of Participants with Cardiovascular (CV) Event post treatment with finerinone therapy
时间窗: 06 months
Includes CV death, non-fatal myocardial infarction, non-fatal stroke, or hospitalization for heart failure (HHF) - forming the composite cardiovascular outcome measure in the finerenone studies.
Number of Participants with Renal Function Decline post finerinone therapy
时间窗: From enrollment to the end of treatment at 06 months
Progressive worsening of kidney function is defined as a sustained ≥40% reduction in eGFR from baseline, progression to kidney failure (ESKD), or renal death.
Number of Participants with Heart Failure (HF) Event post finerinone therapy
时间窗: 6 month
Defined as hospitalization for new or worsening heart failure, confirmed by clinical evidence of fluid overload, raised BNP levels and the requirement for intravenous therapy or hemodynamic support.
eGFR Measurement
时间窗: 06 months
Estimated glomerular filtration rate calculated using the CKD-EPI formula, standardized for body surface area (mL/min/1.73 m²).
Number of Participants with Albuminuria
时间窗: 06 months
Measured as urinary albumin-to-creatinine ratio (UACR), with categories of moderately increased (30-300 mg/g) and severely increased (\>300 mg/g) albuminuria, per KDIGO classification used in the trial protocols.
Number of Participants with Hyperkalaemia post treatment
时间窗: 06 months
Defined as a serum potassium level \>5.5 mmol/L, which served as a safety threshold for dose adjustment or discontinuation in the parent trial data.
次要结局
未报告次要终点
研究者
Muhammad Awais Danish
Dr
Nishtar Medical University