Tacrolimus Versus Prednisolone for the Treatment of Minimal Change Disease

NCT ID: NCT00982072

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2019-10-10

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 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.

Conditions

Minimal Change Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prednisolone

prednisolone tablets

Group Type: ACTIVE_COMPARATOR

prednisolone

Intervention Type: DRUG

Prednisolone 1mg/kg maximum 60mg od

tacrolimus

tacrolimus tablets

Group Type: EXPERIMENTAL

tacrolimus

Intervention Type: DRUG

tacrolimus0.05mg/kg bd (levels 6-12ng/ml)

Interventions

tacrolimus

tacrolimus0.05mg/kg bd (levels 6-12ng/ml)

Intervention Type: DRUG

prednisolone

Prednisolone 1mg/kg maximum 60mg od

Intervention Type: DRUG

Other Intervention Names

prograff

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College Healthcare NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Megan Griffith, MBChBPhDFRCP

Role: STUDY_CHAIR

Imperial College NHS Trust

Tom Cairns, MBBSMRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College NHS Trust

Locations

Hammersmith Hospital

London, , United Kingdom

Countries

United Kingdom

References

Azukaitis K, Palmer SC, Strippoli GF, Hodson EM. Interventions for minimal change disease in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2022 Mar 1;3(3):CD001537. doi: 10.1002/14651858.CD001537.pub5.

Reference Type: DERIVED

PMID: 35230699 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2009-014292-52

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13HH1283

Identifier Type: -

Identifier Source: org_study_id