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临床试验/NCT00982072
NCT00982072已完成4 期

Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease

Imperial College Healthcare NHS Trust1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2009年12月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

prednisolone tablets

干预措施: prednisolone (Drug)

tacrolimus

Experimental

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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