A Prospective, Randomized Controlled Study of Uric Acid on the Progression of IgA Nephropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Renal Function as Measured With eGFR
研究概览
简要总结
This prospective, randomized controlled study will evaluate the effect of uric acid on the progression of IgA nephropathy.
详细描述
It has been reported that hyperuricemia is a risk factor for progression of IgAN. This will be a prospective, randomized study. Eligible IgAN patients will be randomized into the treatment group and the control group. Patients in treatment group will receive allopurinol and usual therapy. Patients in control group will receive usual therapy with placebo. If with hypertension, add the CCB and the β-blocker. Fasting uric acid, serum creatinine, albumin, routine blood test, urine microscopy and dipstick, proteinuria of 24 hours and blood pressure will be measured every month. After followed-up for 6 months, the curative effect of Allopurinol on blood pressure, proteinuria and the progression of IgA nephropathy 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex, more than 18 years old, the range of age is 18 to 70 year old.
- •Biopsy-proven IgA nephropathy.
- •Proteinuria between 0.15g/d and 3.0g/d; and serum albumin level>3.5g/dl.
- •Serum creatinine < 3 mg/dl.
- •Uric acid > 6 mg//dl (360umol/dl) in female; Uric acid >7mg/dl (420umol/dl ) in male.
- •No history of taking ACEI or ARB within 2 weeks.
- •Blood pressure < 180/110 mmHg.
- •Subjects who agree to participate in the study and sign the informed consent.
排除标准
- •Patients who have received prednisone or immunosuppressive drugs within 2 months.
- •Patients who must take ACEI or ARB due to other diseases.
- •Patients who have the history of allergy to allopurinol.
- •Unwillingness to follow the study protocol.
- •Active gout within 4 weeks.
- •Pregnancy or unwillingness to use contraception.
研究组 & 干预措施
Allopurinol
Allopurinol group:allopurinol, 100-300mg/d according to the levels of Scr(serum creatinine) and UA(uric acid), for those Scr < 1.5mg/dl (133 umol/L) at the baseline, allopurinol was given 100 mg three times daily.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
干预措施: allopurinol (Drug)
Control group
Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet and continue their usual therapy.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
干预措施: continue their usual therapy (Other)
结局指标
主要结局
Change in Renal Function as Measured With eGFR
时间窗: baseline and 6 months
次要结局
- The Longitudinal Change in Proteinuria and Blood Pressure(Including Changes in Antihypertensive Drugs Dosing).(baseline and 6 months)
研究者
Xue Qing Yu
Professor
Sun Yat-sen University