Tacrolimus for the Treatment of Systemic Lupus Erythematosus With Membranous Nephritis

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese University of Hong Kong
• Treatments: Tacrolimus

Criteria

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