Study of the Clinical Efficacy and Safety of Finerenone for the Treatment of IGA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 245
- 试验地点
- 1
- 主要终点
- percentage change in PCR from baseline to 6 months
研究概览
简要总结
IgA nephropathy accounts for about 45 per cent of primary glomerular diseases in China and about 26 per cent of renal biopsies in patients with chronic failure.According to current guideline recommendations, there are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
详细描述
Primary IgA nephropathy (IgAN) is an immunopathological diagnostic term for a type of glomerulonephritis characterised by the deposition of IgA or IgA-dominant immune complexes in the glomerular tunica albuginea. And in China IgA nephropathy accounts for about 45% of primary glomerular diseases and about 26% of renal biopsies in patients with chronic failure. Among them, about 15-40% of IgA nephropathy patients progress to renal failure after 10-20 years; IgA nephropathy has become one of the main causes of end-stage renal failure.The nonsteroidal salicorticoid receptor antagonist (MRA)- finerenone reduces the risk of composite renal outcomes, ESKD, or renal death in patients with type 2 diabetes and CKD.There are limited indications for non-steroidal MRAs. Therefore clinical studies to explore the range of clinical indications for fenetyllone are warranted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary IgAN diagnosed by renal biopsy;
- •receive RASI inhibitors for at least 3 months;
- •serum potassium <5 mmol/L;
- •protein-to-creatinine ratio (PCR) >0.3 mg/g
排除标准
- •secondary IgAN;
- •autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, lupus nephritis,;
- •previous renal transplantation;
- •chronic hepatic disease, malignant tumor, active malignancy, heart failure with ejection fraction <40%;
- •followed up less than 6 months;
研究组 & 干预措施
A group: FINE+RASI group;
Patients treated with RASI and finerenone
干预措施: Finerenone (Drug)
A group: FINE+RASI group;
Patients treated with RASI and finerenone
干预措施: RAS inhibitor (Drug)
B group: RASI group;
Patients treated with RASI only
干预措施: RAS inhibitor (Drug)
C group: immune suppressive + FINE + RASI;
Patients receiving immunosuppressive drugs and RASIs
干预措施: Finerenone (Drug)
C group: immune suppressive + FINE + RASI;
Patients receiving immunosuppressive drugs and RASIs
干预措施: RAS inhibitor (Drug)
C group: immune suppressive + FINE + RASI;
Patients receiving immunosuppressive drugs and RASIs
干预措施: Immune Suppressant (Drug)
D group: immune suppressive + RASI;
Patients receiving immunosuppressants, RASI and finerenone
干预措施: RAS inhibitor (Drug)
D group: immune suppressive + RASI;
Patients receiving immunosuppressants, RASI and finerenone
干预措施: Immune Suppressant (Drug)
结局指标
主要结局
percentage change in PCR from baseline to 6 months
时间窗: 6 month
Collect PCR data before enrolment and at month 6 and calculate the percentage change
次要结局
- the level of change in blood sodium(6 month)
- percentage change in PCR from baseline to 1, 2 and 3 months(1, 2 and 3 month)
- frequency of patients with a 30% and 50% decrease in PCR(6 month)
- the level of change in eGFR(6 month)
- the level of change in albumin(6 month)
- the level of change in serum creatinine(6 month)