Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Tacrolimus

Criteria

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