A Prospective Randomized, Controlled, Double Blinded Trial of the Antioxidant Probucol Combined With Valsartan in Patients With IgA Nephropathy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- urinary protein loss whithin 24 hours
研究概览
简要总结
a statement of the study hypothesis:the effect of valsartan in patients with IgA nephropathy have been proved,and the efficacy of probucol in combination with valsartan is to be proved in patients with IgA nephropathy.
This is a prospective randomized controlled, double blinded pilot study to identify the efficacy of probucol in combination with valsartan in patients with IgA nephropathy. The renal function deterioration will be the primary outcome studied. The expected study duration will be 36 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who fulfill the clinical and pathological criteria for IgA nephropathy
- •Age: 18-60 years
- •Renal biopsy diagnostic for IgA nephropathy based on immunohistologic staining for IgA that is greater than or equal to staining for IgG and IgM
- •Urinary protein excretion rate is within the range of 1-2.5g/day
- •Serum creatinine <265.2umol/L at the time of randomization
排除标准
- •Patients who refuse to be randomized for treatment
- •Patients who prefer treatment with conventional agents
- •Patients who are pregnant or plan for pregnancy
- •Patients who are pathologically proven severely or diffusely proliferative IgA nephropathy or crescent glomerulonephritis with >= 50% segmental involvement of the glomeruli and should be treated with other agents,such as immunosuppressive agents or steroid
- •Clinical and histologic evidence of:
- •systemic lupus erythematosus
- •Henoch-Schonlein purpura
- •cirrhosis
- •chronic active liver disease
- •hepatitis B
- •hepatitis C
- •severe chronic diarrhea
- •active peptic ulcer disease
- •acute renal failure
- •malignant hypertension
- •severe heart diseases
- •malignant tumor
- •any systemic infection
- •pregnancy
- •Known contraindication to the administration of probucol and valsartan
研究组 & 干预措施
1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
干预措施: Valsartan (Drug)
1
In arm 1,Valsartan(80-160mg/day) is given to patients in combination with Placebo
干预措施: Placebo (Drug)
2
Valsartan(80-160mg/day) + Probucol(750mg/day)
干预措施: Valsartan (Drug)
2
Valsartan(80-160mg/day) + Probucol(750mg/day)
干预措施: Probucol (Drug)
结局指标
主要结局
urinary protein loss whithin 24 hours
时间窗: 2-3years
次要结局
- renal function(serum Crea or eGFR) deterioration(2-3years)
研究者
Wei Shi
Director of renal division of Guangdong General Hospital
Guangdong Provincial People's Hospital