Study terminated due to poor patient recruitment.

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

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.