Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of End-stage Renal Disease (TCM-WINE)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- First occurrence of progression to continuous renal replacement
研究概览
简要总结
The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of Yi-Qi-Qing-Jie formula (YQF) combined therapy compared with immunosuppression monotherapy in high-risk IgAN.
详细描述
The investigators plan to randomize 60 participants with biopsy-proven IgAN to a YQF combined group (YQF compound combined with prednisolone, and cyclophosphamide if necessary) or an immunosuppression group (placebo-YQF combined with prednisolone, and cyclophosphamide if necessary). The two groups will enter a 48-week in-trial treatment phase and receive post-trial follow-up until 50% (30/60) have a composite endpoint or have been followed for 3 years (study completion). All patients will receive optimal supportive care.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and all other members with clinical involvement in the trial will be blinded to the treatment assignment for the duration of the trial. Relevant personnel have clear divisions of labor and strict permission restrictions. The blinding will be removed only if a participant has severe side effects that the affected participant will be withdrawn.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients who maintain regular follow-ups at Guang'anmen Hospital, agree to participate, and provide informed consent;
- •biopsy-proven IgA nephropathy, with recent progression to high-risk IgAN*;
- •eGFR 15 to 60 ml/min/1.73 m2, calculated with the use of CKD-EPI Creatinine Equation
- •High-risk IgAN: persistent proteinuria ≥ 1 g/d despite at least 8 weeks of optimal supportive care [maximally tolerated RAS blocker which refers to no symptomatic hypotension, no hyperkalemia, and serum creatinine increased by not more than 30% of baseline, blood pressure control meeting targets (135/85 mmHg or lower), and dietary management (sodium intake less than 6 g/d, protein intake of 0.6-0.8 g/kg/day, and low-fat diet)], the mean annual eGFR decline rate (eGFR-slope) >10 ml/min per 1.73 m2 per year, while needing to restart immunosuppressive therapy; or eGFR<60 ml/min/1.73 m2 at the first diagnosis.
排除标准
- •secondary IgAN;
- •comorbidity of other primary or secondary glomerular diseases;
- •comorbidity of severe primary diseases such as cardiovascular, hepatic, cerebral, and hematopoietic system diseases or mental disorders;
- •allergy or intolerance to the experimental medication (e.g., RAS blockers, prednisolone, cyclophosphamide, YQF compound and its placebo compound);
- •contraindications to immunosuppression therapy-acute and chronic infectious diseases, malignancies, leukopenia, thrombocytopenia, gastrointestinal hemorrhage, ulcers of stomach or duodenum, post-transplantation;
- •pregnant or lactating women;
- •unwilling to participate in this study, failure to accept or tolerate Chinese medicine compound;
- •history of alcohol or drug abuse;
- •poor compliance, loss to follow-up;
- •participation in another clinical investigation.
研究组 & 干预措施
Control Group
Optimized supportive care, YQF placebo (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: Immunosuppressants (Drug)
Control Group
Optimized supportive care, YQF placebo (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: Optimized Supportive Care (Other)
Control Group
Optimized supportive care, YQF placebo (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: Yi-Qi-Qing-Jie herbal compound placebo (Other)
YQF Group
Optimized supportive care, YQF (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: The Yi-Qi-Qing-Jie herbal compound (Drug)
YQF Group
Optimized supportive care, YQF (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: Immunosuppressants (Drug)
YQF Group
Optimized supportive care, YQF (oral granule), immunosuppression therapy comprises oral prednisolone plus intravenous cyclophosphamide.
干预措施: Optimized Supportive Care (Other)
结局指标
主要结局
First occurrence of progression to continuous renal replacement
时间窗: Until occurrence or 3 years
Death due to renal disease
时间窗: Until occurrence or 3 years
First occurrence of 40% decrease in eGFR from baseline
时间窗: Baseline, until the first occurrence or 3 years
次要结局
- Proteinuria remission(Week 24, 36, and 48 in the treatment period, and month 6, 12, 24, or 36 if possible)
- Mean annual reduction in eGFR based on SCr(48 weeks)
- The remission rate of symptoms and inflammation status(Week 48)
研究者
Li Shen
Professor & MD.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences