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Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

NCT ID: NCT01206569

Last Updated: 2012-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2012-02-29

Brief Summary

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Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). Around one-third of the patients, however, do not respond to conventional immunosuppressive therapy, and they have a high risk of progressing to dialysis-dependent renal failure. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cell, for example, tacrolimus, may be effective in the treatment of primary glomerulonephritis. The investigators plan to an open-label single-arm study the efficacy and safety of long-acting tacrolimus in the treatment of treatment-resistant lupus nephritis. Twenty-five patients with biopsy-proven lupus nephritis will be recruited. They will be treated with oral prednisolone and long-acting tacrolimus for 6 months, followed by 6 months of maintenance steroid and azathioprine. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. This study will explore the potential role of long-acting tacrolimus in resistant lupus nephritis, which has a poor prognosis and no effective treatment at the moment.

Detailed Description

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Conditions

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Lupus Nephritis

Keywords

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glomerulonephritis systemic lupus erythematosus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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advagraf

Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.

Group Type EXPERIMENTAL

Long-acting tacrolimus (Advagraf, Astellas Pharma)

Intervention Type DRUG

Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.

Interventions

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Long-acting tacrolimus (Advagraf, Astellas Pharma)

Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age over 18 with informed consent.
* Fulfill the revised American College of Rheumatology criteria for SLE
* Biopsy-proven class III, IV, or V lupus nephritis within the past 24 months.
* Could not achieve complete remission after at least 4 months of conventional therapy (oral steroid plus cyclosphosphamide or mycophenolate mofetil).
* NB. Complete response is defined as proteinuria less than 0.5 g/day, with normal urinary sediment, a normal serum albumin concentration, and serum creatinine \<15% above the base-line value.
* Female patients of child-bearing age and male patients agree to maintain effective birth control practice during the study.

Exclusion Criteria

* Abnormal liver function tests
* Hepatitis B surface antigen or hepatitis C antibody positive
* Diabetic
* Receiving NSAID or other agents known to influence urinary
* Protein excretion
* Allergic or intolerant to macrolide antibiotics or tacrolimus
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheuk-Chun SZETO

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Prince of Wales Hospital

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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AFKLN

Identifier Type: -

Identifier Source: org_study_id