Long-Acting Tacrolimus for the Treatment of Resistant Lupus Nephritis
Status:
Completed
Trial end date:
2012-02-01
Target enrollment:
Participant gender:
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.