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

• Status: Terminated
• Trial end date: 2016-04-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Astellas Pharma Korea, Inc.
• Treatments: Tacrolimus

Criteria

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