Validity and Security of Reh-acteoside Therapy for Patients of IgA Nephropathy -- A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Remission of proteinuria (complete or partial)
研究概览
简要总结
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy.
详细描述
Reh-acteoside (general acteoside of rehmanniae leaves) contains more than 10 kinds of bio-active mucopolysaeccharide, among which acteoside is the most effective ingredient, constituting 30 percent. It has been reported that acteoside can reduce mesangium lesion of IgA nephrology-model ddy-mice, mainly by reducing the expressing of TGF-β1, reducing proliferation of mesangial cell and glomerular sclerosis. Research also suggested that conjunctive use of reh-acteoside and benazepril showed better effect on reducing proteinurine than single use of benazepril, with no obvious side effect at the same time. Thus, we start this clinical trial to evaluate the effect and security of reh-acteoside therapy for patients of IgA nephropathy. We set 3 groups: methylprednisolone group, reh-acteoside group and methylprednisolone with reh-acteoside group. After followed-up for 8 weeks, remission of proteinuria and change of renal function will be evaluated.
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
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 14~70 years, regardless of gender Clinical evaluation and renal biopsy diagnostic for IgA nephropathy. Average urinary protein excretion of 1.0~3.5g/24h on two successive examinations.
- •eGFR ≥ 50 ml/min/1.73 m2 Willingness to sign an informed consent (patients under 18 years old need legal guardian to sign).
排除标准
- •Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
- •Rapidly progressive nephritic syndrome (crescent formation≥50%). Acute renal failure, including rapidly progressive IgAN. Renal biopsy suggests active pathological change (cellular crescent, loop necrosis, micro-thrombosis formation) Current or recent (within 30 days) exposure to steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
- •Recent acute hepatitis (in 2 weeks), chronic active hepatitis (hepatitis B or hepatitis C infection), a rise more than 2.5 folds of current ALT, AST or TBil level.
- •History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
- •Any Active systemic infection or history of serious infection within one month. Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
- •Active tuberculosis Malignant hypertension that is difficult to be controlled by oral drugs. Known allergy, contraindication or intolerance to the steroids. Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
- •Malignant tumors Excessive drinking or drug abuse Mental aberrations Current or recent (within 30 days) exposure to any other investigational drugs.
研究组 & 干预措施
Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
干预措施: Prednisolone (Drug)
Reh-acteoside
Oral take reh-acteoside (0.4g bid) for 8 weeks
干预措施: Reh-acteoside (Drug)
Reh-acteoside+Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks
干预措施: Prednisolone (Drug)
Reh-acteoside+Prednisolone
Oral take prednisolone (0.5 mg/kg, qd) and reh-acteoside (0.4g bid) for 8 weeks
干预措施: Reh-acteoside (Drug)
结局指标
主要结局
Remission of proteinuria (complete or partial)
时间窗: up to 8 weeks
Complete remission: UPCR (urinary protein creatinine ratio) \<300mg/g, plasma albumin in normal range, and stable serum creatinine level (fluctuation range \<15%)； Partial remission: UPCR decreases more than 50% from baseline, plasma albumin \>30g/L, and stable serum creatinine level (fluctuation range \<15%).
次要结局
- Deacrase of hematuria(up to 8 weeks)
- Deterioration of renal function(up to 8 weeks)
研究者
Yanhong Deng
The Sixth Affiliated Hospital of Sun Yat-Sen University
Sun Yat-sen University