A Phase 4 interventional study of tacrolimus in Lupus Nephritis and Lupus Erythematosus, Systemic, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-03.
Sponsored by Chinese University of Hong Kong · Phase 4, Interventional, and Treatment
The investigators study the efficacy and safety of tacrolimus in the treatment of membranous nephritis secondary to systemic lupus erythematosus.
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.
245 studies on the registry are indexed under Nephritis; 56 are open to participants now.
This study's enrollment of 20 is below the median of 49 across 156 interventional studies indexed under Nephritis.
Browse Nephritis studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
Change in 24-hour urinary protein excretion
Development of renal flare
Development of non-renal flare
This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong