Clinical Trial: Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Imperial College Healthcare NHS Trust

Current Primary Outcome: Proportion of patients achieving complete remission from nephrotic syndrome (normalisation of serum albumin and urine PCR <50 units) at 8 weeks [ Time Frame: 8 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of patients achieving complete remission from nephrotic syndrome at 16 and 24 weeks [ Time Frame: 16 and 24 weeks ]
  • Proportion of patients achieving remission who then relapse [ Time Frame: 2 years ]
  • Nature severity and frequency of adverse events [ Time Frame: 3 years ]
  • change in baseline glomerular filtration rate [ Time Frame: 3 years ]


Original Secondary Outcome:

  • Proportion of patients achieving complete remission from nephrotic syndrome at 16 and 24 weeks [ Time Frame: 16 and 24 weeks ]
  • Proportion of patients achieving remission who then relapse [ Time Frame: 2 years ]
  • Nature severity and frequency of adverse events [ Time Frame: 3 years ]
  • change in baseline GFR [ Time Frame: 3 years ]


Information By: Imperial College Healthcare NHS Trust

Dates:
Date Received: September 21, 2009
Date Started: December 2009
Date Completion: December 2019
Last Updated: March 3, 2017
Last Verified: March 2017