Treatment of IgA Nephropathy According to Renal Lesions
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Failure at 24 months
研究概览
简要总结
TIGER study (Treatment of IgA nEphropathy according to Renal lesions) is a prospective openly randomized controlled study.
The main objective is to evaluate the efficacy of early corticotherapy + Renin Angiotensin System (RAS) blockade or inhibitors of Sodium glucose transporter 2 (SGLT2i) (versus RAS blockade or SGLT2i alone) after two years of evolution in IgAN patients with severe histological lesions.
详细描述
Currently, IgAN treatment recommendations are only based on clinico-biological parameters. Steroids therapy appears to have a major role in IgAN treatment, but previous studies evaluating steroids lacked of optimal control group and reproducible evaluation criteria. No prospective study with optimal nephroprotection had included renal pathology in patients selection criteria, although histological evaluation improves patients prognosis prediction. Until now, the lack of a reliable histological classification has precluded the use of histological lesions to evaluate IgAN prognosis and treatment. Given the recently identified major prognostic role of histological lesions in IgAN, we propose to introduce renal pathology to guide the treatment of IgAN in a multicenter study, using currently validated evaluation criteria of chronic kidney disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Age >= 18 years
- •Patient with IgAN
- •Renal biopsy < 45 days before inclusion visit
- •PCR ratio >0.75 g/g (within 30 days before or after the renal biopsy)
- •Renal biopsy with at least 8 glomeruli, disclosing at least 2 criteria among:
- •mesangial proliferation (according to Oxford criteria)
- •endocapillary proliferation (according to Oxford criteria)
- •tubulointerstitial fibrosis (according to Oxford criteria) >25% of the biopsy
- •segmental glomerulosclerosis (according to Oxford criteria)
- •at least 1 cellular/fibrocellular crescents (C1 according to Oxford criteria)
- •Patient with Social Security Insurance or CMU
- •Patient having signed an informed consent
排除标准
- •>30% increase of serum creatinine after starting nephroprotection therapy (≥ 15 days and ≤ 6 weeks) only for patient under nephroprotection <45 days of the inclusion visit
- •>50% cellular/fibrocellular crescents, or >50% tubulointerstitial fibrosis or >50% globally sclerotic glomeruli
- •Nephrotic syndrome with minimal change disease and IgA deposits
- •eGFR <20 ml/min/1,73m2 (CKD-EPI formula) within 30 days before or after the renal biopsy
- •Uncontrolled blood pressure (Systolic blood pressure >180 mmHg or diastolic blood pressure > 110 mmHg)
- •Previous corticosteroids treatment (>20 mg/d during more than 15 days, within the last 3 months before the renal biopsy)
- •Pregnancy or breast feeding or women without sufficient contraception
- •Secondary known forms of IgAN
- •Henoch-Schoenlein purpura
- •Additional other chronic renal disease
- •Contraindication for immunosuppressive therapy, including active intestinal bleeding, active gastric or duodenal ulcer; active infection; any malignancy in a last years before the inclusion; severe psychiatric disease; living vaccines; anti-inflammatory dosages of acetylsalicylic acid
- •Contraindication for RAS orSGLT2i blockade therapy
- •Known allergy or intolerance to corticoids or lactose
- •Organ transplant patient
研究组 & 干预措施
CONTROL
Treatment with Renin Angiotensin system (RAS) blockade or SGLT2i.
干预措施: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i) (Drug)
EXPERIMENTAL
Corticotherapy + RAS blockade or SGLT2i treatment. Drug injection (intravenous) + tablets
干预措施: corticotherapy (Drug)
EXPERIMENTAL
Corticotherapy + RAS blockade or SGLT2i treatment. Drug injection (intravenous) + tablets
干预措施: Renin Angiotensin system (RAS) blockade or Inhibitors of sodium glucose transporter 2 (SGLT2i) (Drug)
结局指标
主要结局
Failure at 24 months
时间窗: Month 24
Failure at 24 months will be defined as : * Proteinuria/creatinuria ratio (PCR) \> 0,5 g/g * or mGFR \< 80% of initial mGFR (or eGFR if unavailable) * or loss of more than 10 ml/min/1,73m2 of initial mGFR (or eGFR if unavailable) * or end stage renal disease (ESRD) * or renal transplantation * or death
次要结局
- Failure at 6 months(Month 6)
- Proportion of patients with persistent severe histological lesions in repeat kidney biopsy at 12 months(Month 12)
- Evolution of GFR at 12 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 12 months(Month 12)
- Evolution of GFR at 24 months assessed as :- the absolute value of GFR - the absolute difference of GFR from the baseline - the annual degradation (ml/min /1,73m2/year) of GFR during the 24 months(Month 24)
- Prognosis markers of failure at 24 months(Month 24)
- Failure at 12 months(Month 12)
- Evolution of proteinuria assessed as : - the absolute value of proteinuria at 12 and 24 months - the absolute difference of proteinuria from baseline at 12 and 24 months(Month 12 and 24)
- SF36 scale at 24 months(Month 24)
- Number of side effects(Month 24)
- SF36 scale at 12 months(Month 12)