NCT00125307

Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.

Detailed description

Glomerulonephritis is one of the major disease manifestations of systemic lupus erythematosus (SLE). The treatment of membranous (type V) lupus nephritis, a subset that carries a high morbidity, remains unsatisfactory. Recent studies suggest that immunosuppressive therapy targeted against the calcineurin pathway of T-helper cells, for example, tacrolimus, may be effective in the treatment of primary membranous nephropathy. The investigators plan to conduct an open-label single-arm study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy secondary to SLE. Twenty patients with biopsy-proven membranous nephropathy secondary to SLE will be recruited. They will be treated with oral prednisolone and tacrolimus for 6 months, followed by 6 months of maintenance steroids alone. Proteinuria, renal function, clinical and serologic lupus activity will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.5 gm/day. This study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis, which is usually resistant to conventional therapy.

Conditions

• Lupus Nephritis
• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	tacrolimus

Timeline

• Start date: 2004-01-01
• Primary completion: 2007-10-01
• Completion: 2008-02-01
• First posted: 2005-08-01
• Last updated: 2015-08-03

Locations

1 site across 1 country: Hong Kong