Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Lupus Nephritis Clinical Trial

Official title:

Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00125307
• Other study ID #: CRE-2004.229-T
• Secondary ID: CRE-2004.229-T
• Status: Completed
• Phase: Phase 4
• First received: July 29, 2005
• Last updated: July 31, 2015
• Start date: January 2004
• Est. completion date: February 2008

Study information

• Verified date: May 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics CommitteeHong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2008
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Fulfill the revised American College of Rheumatology criteria for SLE

• Have biopsy-proven membranous nephropathy secondary to SLE

• Nephrotic syndrome with proteinuria (> 3 g/day) and serum albumin < 30 g/dl, with or without active urinary sediments despite steroid therapy (with or without cytotoxic agents)

• Age over 18 with informed consent

• Female patients of child-bearing age and male patients who agree to maintain effective birth control practice during the study

Exclusion Criteria:

• Patient with abnormal liver function tests

• Patient with hepatitis B surface antigen or who is hepatitis C antibody positive

• Patient who is diabetic

• Patient who is receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other agents known to influence urinary protein excretion

• Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Lupus Nephritis
• Nephritis

Intervention

Drug:
• tacrolimus

Locations

Country	Name	City	State
Hong Kong	Department of Medicine & Therapeutics, Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 24-hour urinary protein excretion
Secondary	Development of renal flare
Secondary	Development of non-renal flare