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

April 9, 2021 updated by: Imperial College Healthcare NHS Trust

Tacrolimus vs Prednisolone for the Treatment Minimal Change Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • prograff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Complete Remission From Nephrotic Syndrome at 8 Weeks
Time Frame: 8 weeks
normalisation of serum albumin and urine PCR <50 units
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Patients Achieving Complete Remission From Nephrotic Syndrome at 16 and 26 Weeks
Time Frame: 16 and 26 weeks
16 and 26 weeks
Percentage of Patients Achieving Remission Who Then Relapse
Time Frame: 2 years
2 years
Number of Serious Adverse Events
Time Frame: 3 years
3 years
Change in Baseline Glomerular Filtration Rate
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Study Chair: Megan Griffith, MBChBPhDFRCP, Imperial College NHS Trust
  • Principal Investigator: Tom Cairns, MBBSMRCP, Imperial College NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

October 10, 2019

Study Completion (Actual)

October 10, 2019

Study Registration Dates

First Submitted

September 21, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Actual)

May 4, 2021

Last Update Submitted That Met QC Criteria

April 9, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13HH1283
  • 2009-014292-52 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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