A Randomized Controlled Trial of Mycophenolate Mofetil in Patients With IgA Nephropathy
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Change in Proteinuria - Uprotein/Creatinine Ratio
研究概览
简要总结
IgA nephropathy (IgAN) is the most common type of glomerulonephritis worldwide. 15-40% of individuals diagnosed with IgAN, including children, will eventually progress to chronic renal insufficiency (CRI) and end stage renal disease (ESRD). The study is to evaluate the safety and benefits of MMF in patients with IgAN who have been pre-treated (and continue to be treated) with angiotensin converting enzyme inhibitors (ACEi) and fish oil supplements (FOS).
详细描述
A multi-center, randomized, controlled clinical trial to test the hypothesis that treatment with mycophenolate mofetil (MMF) will lead to significant and sustained improvement in proteinuria in patients with IgA Nephropathy who have been pre-treated (and continue to be treated) with ACEi and FOS compared to a placebo control group of patients receiving comparable doses of ACEi and FOS without MMF. Data for this outcome will be examined every six months and at the end of 2 years of study. Comparisons will be made between the two treatment groups for change from entry level in urine protein to creatinine (UPr/Cr) ratio, 24-hour urine protein excretion rate and estimated glomerular filtration rate (GFR).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ages 7-70 years old
- •Renal biopsy, diagnostic for IgA nephropathy
- •Must be able to take oral medication
排除标准
- •Clinical and histologic evidence of systemic lupus erythematosus
- •Well-documented history of Henoch-Schonlein purpura.
- •Clinical evidence of cirrhosis or chronic liver disease
- •Abnormal laboratory values at the time of study entry
- •Estimated GFR outside of protocol defined limits
- •History of significant gastrointestinal disorder
- •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 or malignancy
- •Current or prior treatment with MMF or azathioprine
研究组 & 干预措施
Mycophenolate Mofetil (MMF)
Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
干预措施: Mycophenolate Mofetil (MMF) (Drug)
Mycophenolate Mofetil (MMF)
Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
干预措施: ACEi (Drug)
Mycophenolate Mofetil (MMF)
Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.
干预措施: FOS (Drug)
MMF Placebo
Subjects receive MMF placebo.
干预措施: MMF Placebo (Drug)
MMF Placebo
Subjects receive MMF placebo.
干预措施: ACEi (Drug)
MMF Placebo
Subjects receive MMF placebo.
干预措施: FOS (Drug)
结局指标
主要结局
Change in Proteinuria - Uprotein/Creatinine Ratio
时间窗: Plan was to measure uprotein/creatinine ratio for 12 months on MMF or placebo, and then 12 months post-treatment. Data given after 6 months MMF/placebo.
Urine protein/creatinine ratio after 6 months treatment with MMF or placebo.
次要结局
- Change in Estimated Glomerular Filtration Rate (GFR) to Less Than 60% of the Baseline Level(12 months)