Effectiveness of Immunosuppression Combined With Tonsillectomy in Caucasian Patients With High-risk IgA-nephropathy (the Pragmatic Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Progression
研究概览
简要总结
The open-label prospective non-randomised controlled aims to assess the efficacy of the combination of immunosupression (IST) and tonsillectomy (TE) in Caucasian patients at high risk of the IgA-nephropathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary IgA-nephropathy (IgAN) patients with:
- •DP >1 g with haematuria (>5 RBC/HPF)
- •DP <1 g with haematuria AND probability of starting dialysis within 5 years >11% (estimated by the International risk-prediction tool in IgAN) AND at least one of the following histologic changes: at least one of the following histologic changes: mesangial proliferation, endocapillary hypercellularity, cellular crescents
排除标准
- •Age <18 or >75 years;
- •eGFR ≤20 ml/min/1.73m2
- •Patients with mild renal lesions (M0, E0, S0, T0, C0), minor urinary findings, DP <1.0 g
- •Contraindications to IST or TE
- •Patients with any co-existing kidney disease
- •Patients with secondary IgAN (Schoenlein-Henoch purpura, liver cirrhosis, etc.)
- •Patients with diabetes mellitus
- •Any clinically significant acute illness within 60 days prior to kidney biopsy (including infection, aseptic necrosis of any bone, patients with myocardial infarction or cerebrovascular stroke, other conditions that can be exacerbated by corticosteroids
- •Incomplete empiric IST administered prior to kidney biopsy
研究组 & 干预措施
Immunosuppression combined with tonsillectomy (IST+TE group)
Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).
干预措施: Immunosuppressive treatment (Drug)
Immunosuppression combined with tonsillectomy (IST+TE group)
Experimental group comprises patients, who will receive immunosuppression combined with tonsillectomy (the IST+TE group, n=120).
干预措施: Tonsillectomy (Procedure)
Control group (Active comparator): IST without TE (IST group)
Сontrol group includes subjects with the same eligibility criteria and who will underwent only IST without TE in the same time period.
干预措施: Immunosuppressive treatment (Drug)
结局指标
主要结局
Progression
时间窗: From date of inclusion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months
The composite end-point of disease progression includes: eGFR decline \>40% of baseline level, ESKD (defined as long-term eGFR \<15 ml/min/1.73m2 for more than 3 months or need of initiation of renal replacement therapy (RRT).
Overall remission (partial or complete remission)
时间窗: From date of inclusion until the date of first documented overall remission, assessed up to 120 months
Partial remission (PR) is defined as a decrease in proteinuria by more than 50% in cases with baseline daily proteinuria (DP) \<3.5 g, and in those with DP ≥3.5 g, as its decrease \>50% to level \<3.5 g/day in combination with regression of hematuria by at least 70% (in 3 consecutive measurements). Complete remission (CR) is defined as DP \<0.5 g/day and the disappearance of hematuria (URBC \<5/HPF). Any remission is registered in the absence of eGFR decrease \>20% from the baseline.
Time to clinical remission
时间窗: From date of inclusion until the date of first documented remission, assessed up to 120 months
Cumulative rate of overall (partial or complete) clinical remission
次要结局
- Partial remission(From date of inclusion until the date of first documented partial remission, assessed up to 120 months)
- Relapses(From date of inclusion until the date of first documented relapse, assessed up to 120 months)
- Adverse events per 100 patient-years(From date of inclusion until the date of first documented AE, assessed up to 120 months)
- Complete remission(From date of inclusion until the date of first documented complete remission, assessed up to 120 months)
- The change in eGFR(Through study completion, an average of 120 months)
- The change in proteinuria(Through study completion, an average of 120 months)
研究者
Ivan S Moiseev
Vice-director for science RM Gorbacheva Institute
St. Petersburg State Pavlov Medical University