Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

The Chinese University of Hong Kong

Status and phase: Completed; Phase 4

Conditions: Lupus Nephritis

Treatments: Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)

Study type: Interventional

Funder types: Other

Identifiers

NCT01206569

AFKLN

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

advagraf

Experimental group

Description:

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

Treatment:

Drug: Long-acting tacrolimus (Advagraf, Astellas Pharma)