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临床试验/NCT07056595
NCT07056595招募中不适用

Finerenone in Patients With IgA-nephropathy: Prospective Interventional Trial

Botkin Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月21日最近更新:
干预措施

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

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

Experimental

干预措施: Finerenone (Drug)

iSGLT2

Experimental

干预措施: Finerenone (Drug)

iRAS+iSGLT2

Experimental

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

发起方
Botkin Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Evgeny Shutov

Senior Researcher

Botkin Hospital

研究点 (1)

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