A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients

A Multicenter, Non-comparative, Open-labeled, Prospective Study to Evaluate the Efficacy and Safety of Tacrolimus (Prograf®) With Steroid in Korean Lupus Nephritis Patients Who Are Non-responders to Steroid Monotherapy

This study is to evaluate efficacy and safety of tacrolimus with steroid by observing remission rate at 24 weeks in lupus nephritis patients who are non-responders to steroid monotherapy.

Inclusion Criteria:

• Patients who satisfy more than 4 criteria for diagnosis of systemic lupus erythematosus (ARA criteria, 1982)
• Patients who fall under WHO class III-IV lupus nephritis on renal biopsy
• Patients with refractory lupus nephritis
• Proteinuria ≥ 0.5 g/day
• Patients who took steroid ≥ 20 mg/day over one month prior to the study
• Patients who failed a first-line therapy (non-responders to steroid monotherapy)

Exclusion Criteria:

• Patients who are allergic or resistant to macrolide antibiotics or tacrolimus
• Patients who received tacrolimus in the past (excluding drugs for external use)
• Patients who used other immunosuppressants within 4 weeks before initiation of the study
• Patients who have been receiving systematic chemotherapy since before enrollment (local chemotherapy is allowed.)
• Patients with malignant tumor which developed within the recent 5 years or history of malignant tumor
• Patients who have severe diarrhea, vomiting, active peptic ulcer or gastrointestinal disorders which may influence absorption of tacrolimus
• Patients with S-Cr ≥ 200 µ㏖/L or ≥ 2.3 mg/dL
• Patients with liver function levels of more than twice the upper limit of normal or acute active hepatitis