Mycophenolate Mofetil and Tacrolimus vs Tacrolimus Alone for the Treatment of Idiopathic Membranous Glomerulonephritis (IMG)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Number of Patient Who Gained Remission From the Nephrotic Syndrome
研究概览
简要总结
Study Hypothesis: When mycophenolate mofetil is added to tacrolimus in the treatment of membranous glomerulonephritis it is likely to improve the initial response to treatment and reduce the risk of relapse on stopping therapy.
详细描述
Membranous nephropathy is a common cause of nephrotic syndrome in adults. It is difficult to treat and if persistent leads to end stage renal failure in a significant number of patients. It is currently treated in this institution with tacrolimus monotherapy. This is effective in the majority of patients in reducing proteinuria but the remissions are often partial and patients tend to relapse when the tacrolimus treatment is stopped. We propose to use mycophenolate mofetil in combination with tacrolimus with the aim of obtaining a more complete initial response to treatment, a decreased rate of relapse on withdrawal of therapy and less progression of renal failure. This will be a randomised control trial, patients will be randomised to receive treatment with tacrolimus alone (our current standard therapy)or treatment with tacrolimus and mycophenolate mofetil. Participants will receive treatment for up to 2 years and then be monitored for relapse of their nephrotic syndrome.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Idiopathic membranous glomerulonephritis on renal biopsy
- •Proteinuria - protein/creatinine ratio (PCR) > 100 units with hypoalbuminaemia or PCR > 300 units with normal serum albumin despite 3 months treatment with maximum tolerated doses of ace inhibitors and angiotensin 2 antagonists (or shorter if life threatening complications of nephrotic syndrome require institution of immediate immunosuppression)
- •Male or female patients aged 18 to 80 years
排除标准
- •Hepatitis B hepatitis C or HIV positive
- •Malignancy (all patients must have a CT chest abdomen and pelvis and other investigations if clinically indicated)
- •Untreated infection
- •Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception
- •Any condition judged by the investigator that would cause the study to be detrimental to the patient
研究组 & 干预措施
tacrolimus
Intervention type -drug tacrolimus therapy 2mg bd adjust to obtain levels of 5-12ng/L
干预措施: tacrolimus (Drug)
tacrolimus and mycophenolate mofetil
tacrolimus 2mgs bd (adjusted to obtain levels 5-12mg/L and mycophenolate mofetil 500mg bd adjusted to obtain levels 1.5-3mg/L
干预措施: tacrolimus and mycophenolate mofetil (Drug)
结局指标
主要结局
Number of Patient Who Gained Remission From the Nephrotic Syndrome
时间窗: 10-109 weeks
Efficacy of mycophenolate in preventing relapse of nephrotic syndrome secondary to membranous glomerulonephritis on withdrawal of tacrolimus therapy.
次要结局
- Number of Patients Achieved Remission(6-12 months)