Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Median change in albuminuria from baseline
研究概览
简要总结
: IgA-nephropathy is the most common glomerulonephritis with the unfavorable prognosis in patients with persistent albuminuria. Finerenone is a new nonsteroidal mineralocorticoid receptor antagonist that has demonstrated efficacy in reducing albuminuria in patients with CKD and type 2 diabetes in two major trials, FIGARO-DKD and FIDELIO. This finding supported the approval of finerenone by the U.S. Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD). A subgroup analysis in the pooled FIDELITY trial demonstrated that in patients with CKD stages 1-4 and type 2 diabetes (T2D), the cardio- and nephroprotective effects of finerenone were independent of concomitant therapy with SGLT-2 inhibitors or GLP-1 receptor agonists. Thus, the role of finerenone in slowing CKD progression in T2D can be considered well-established. Given its albuminuria-reducing effects, finerenone is being investigated in multiple trials, including studies on non-diabetic kidney disease and IgA nephropathy, though no published results are available yet. In this trial finerenone will be used as a nephroprotective agent above standard treatment in terms of assessing adverse events and potential efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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 (> 18 years) with the primary IgAN diagnosed by kidney biopsy;
- •Treatment with stable doses of iRAS or/and iSGLT2 inhibitors for at least 3 months prior inclusion into the trial;
- •Blood pressure < 140/90 mm Hg
- •24-hour urinary albumin excretion > 300 mg
排除标准
- •Kidney transplantation in medical history
- •Chronic hepatic disease, including hepatitis, malignant tumor, active malignancy;
- •Heart failure with ejection fraction <40%;
- •Acute myocardial infarction and/or stroke less then 3 months before including in trial;
- •Presence ANCA in serum
- •Ongoing immunosuppressive treatment
- •eGFR < 20 ml/min
- •Pregnancy and breastfeeding
- •Uncontrolled blood pressure
研究组 & 干预措施
iRAS
干预措施: Finerenone (Drug)
iSGLT2
干预措施: Finerenone (Drug)
iRAS+iSGLT2
干预措施: Finerenone (Drug)
结局指标
主要结局
Median change in albuminuria from baseline
时间窗: 6 months
24-hour urinary albumin excretion
次要结局
未报告次要终点
研究者
Evgeny Shutov
Senior Researcher
Botkin Hospital
