Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks
研究概览
简要总结
The purpose of this study is to compare the effectiveness of tacrolimus (prograf) versus prednisolone for the treatment of nephrotic syndrome secondary to minimal change disease.
详细描述
Minimal change disease is a common cause of nephrotic syndrome in adults. Standard treatment is with high dose steroids which is often effective in controlling the nephrotic syndrome but has a high morbidity due to the side effects of the steroids. There is also a high relapse rate,therefore many patients require long term steroid therapy to control their disease which has significant morbidity and mortality. Some patients are or also become steroid resistant. There are studies showing the effectiveness of alkylating agents such as cyclophosphamide but the use of these drugs is limited by their toxicity, including increased rates of infection, cancers and infertility.
Tacrolimus (prograf) is a T-cell specific calcineurin inhibitor that shares similar immunosuppressive actions with cyclosporine A.In other glomerular diseases such as focal segmental glomerulosclerosis and membranous glomerulonephritis, prograf has been shown to be a very effective treatment for proteinuria. This may be due to the immunomodulatory effects on the underlying disease, but there may also be a direct effect of tacrolimus (prograf) on the podocyte, stabilising the actin cytoskeleton and therefore decreasing protein leak.Therefore tacrolimus (prograf) is likely to be effective in reducing proteinuria in minimal change disease.It has also been shown to have a good side effect profile when used to allow the avoidance of steroids in transplantation.This study aims to prospectively study if tacrolimus (prograf) is effective as treatment for minimal change disease compared with standard therapy with steroids, and whether it has advantages in terms of side effect profile and prevention of relapse.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) > 100units), secondary to minimal change disease.
- •Age over 18.
排除标准
- •Hepatitis B, hepatitis C or HIV infection.
- •Untreated infection.
- •Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception.
- •Patients who have been treated with immunosuppression over the last 18 months.
- •Patients who have had more than 3 relapses of nephrotic syndrome within 5 years.
- •Any condition judged by the investigator that would cause the study to be detrimental to the patient.
研究组 & 干预措施
prednisolone
prednisolone tablets
干预措施: prednisolone (Drug)
tacrolimus
tacrolimus tablets
干预措施: tacrolimus (Drug)
结局指标
主要结局
Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks
时间窗: 8 weeks
normalisation of serum albumin and urine PCR \<50 units
次要结局
- Percentage of Patients Achieving Remission Who Then Relapse(2 years)
- Number of Serious Adverse Events(3 years)
- Change in Baseline Glomerular Filtration Rate(3 years)
- Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks(16 and 26 weeks)
