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Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease (MinTAC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00982072
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):
Imperial College Healthcare NHS Trust

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.

Condition or disease Intervention/treatment Phase
Minimal Change Disease Drug: tacrolimus Drug: prednisolone Phase 4

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease
Actual Study Start Date : December 2009
Actual Primary Completion Date : October 10, 2019
Actual Study Completion Date : October 10, 2019

Arm Intervention/treatment
Active Comparator: prednisolone
prednisolone tablets
Drug: prednisolone
Prednisolone 1mg/kg maximum 60mg od

Experimental: tacrolimus
tacrolimus tablets
Drug: tacrolimus
tacrolimus0.05mg/kg bd (levels 6-12ng/ml)
Other Name: prograff

Primary Outcome Measures :
  1. 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with nephrotic syndrome (hypoalbuminaemia and protein creatinine ratio (PCR) > 100units), secondary to minimal change disease.
  • Age over 18.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00982072

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United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
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Study Chair: Megan Griffith, MBChBPhDFRCP Imperial College NHS Trust
Principal Investigator: Tom Cairns, MBBSMRCP Imperial College NHS Trust
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Responsible Party: Imperial College Healthcare NHS Trust Identifier: NCT00982072    
Other Study ID Numbers: 13HH1283
2009-014292-52 ( EudraCT Number )
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
nephrotic minimal change tacrolimus prednisolone
Additional relevant MeSH terms:
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Nephrosis, Lipoid
Kidney Diseases
Urologic Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents