Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00125307
Status:
COMPLETED
Last Update Posted:
2015-08-03
First Post:
2005-07-29
Brief Title:
Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 05 gmday This study will explore the potential role of tacrolimus in the treatment of membranous lupus nephritis which is usually resistant to conventional therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CRE-2004229-T | None | None | None |