NCT02471599暂停不适用
Effect of Tonsillectomy on Longterm Renal Outcome of IgA Nephropathy :a Prospective,Randomized,Controlled Study.
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Renal survival rate or Deterioration of renal function
研究概览
简要总结
The effect of tonsillectomy therapy on IgA nephropathy is still controversial.Few prospective,randomized investigations have examined how tonsillectomy affects the shortterm and longterm renal outcome of IgA nephropathy.This is A prospective,randomized ,controlled study to explore the longterm effect of tonsillectomy for patients with IgA nephropathy.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willingness to sign an informed consent
- •Age:18~45 years, regardless of gender
- •Clinical evaluation and renal biopsy diagnostic for immunoglobulin A nephropathy (IgAN), excluded secondary IgAN. Renal histological criteria should be defined by Lee's glomerular grading system.
- •Any one of three Tonsilar conditions defined by Otorhinolaryngologist : 1,recurrent acute tonsillitis accompanied with gross hematuria or urinary findings abnormality；2,recurrent acute tonsillitis without gross hematuria，but tonsil provocation test was positive；3, No history of acute tonsillitis,body examination found hypertrophy or atrophy tonsils ,crypt pus of tonsils ,or scars on the tonsil surface ,and positive tonsil provocation test.
- •Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2
排除标准
- •Inability or unwillingness to sign the informed consent
- •Inability or unwillingness to meet the scheme demands raised by the investigators
- •Rapidly progressive nephritic syndrome and acute renal failure, 24-hour urine protein≥3.5g,including rapidly progressive IgAN (IgAN with rapid decline in renal function characterized histologically by necrotizing vasculitis and crescent formation≥30%) necessitating the use of other immunosuppressive agents.
- •Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis
- •est GFR < 30 mL/min/1.73m2
- •Malignant hypertension that is difficult to be controlled by oral drugs
- •Cirrhosis, chronic active liver disease.
- •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 of entry or known infection with HIV, hepatitis B, or hepatitis C.
- •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)
- •Malignant tumors (except fully cured basal cell carcinoma)
- •Current or recent (within 30 days) exposure to any other investigation
- •Current exposure to mycophenolic mofetil (MMF),azathioprine or corticosteroids. In case of current treatment with oral steroid ,entry is permitted after corticosteroids dosage below 0.4mg/kg per day.
- •Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception
- •Tonsillectomy had been done when IgAN diagnosis or known contraindication to tonsillectomy(such as neutropenia，bleeding tendency，or anatomic abnormalities）
研究组 & 干预措施
tonsillectomy group
Experimental
The case group will receive tonsillectomy.
干预措施: tonsillectomy (Procedure)
non-tonsillectomy group
Active Comparator
The controlled group will not receive tonsillectomy.
干预措施: non-tonsillectomy (Other)
结局指标
主要结局
Renal survival rate or Deterioration of renal function
时间窗: Every 12months for 10 years after tonsillectomy
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline estimated glomerular filtration rate (eGFR) levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation)after tonsillectomy
次要结局
- Remission of proteinuria (complete or partial)(every 3-12months for 10 years after tonsillectomy)
- Repeat renal biopsy(the fifth and tenth year after tonsillectomy)
- Remission of hematuria (complete or partial)(every 3-12months for 10 years after tonsillectomy)
- Side effects(every 3-12months for 10 years after tonsillectomy)
研究者
Xue Qing Yu
Professor
Sun Yat-sen University
研究点 (1)
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