A Study to Evaluate the Efficacy and Safety of Tacrolimus With Steroid in Korean Lupus Nephritis Patients
- Registration Number
- NCT01316133
- Lead Sponsor
- Astellas Pharma Korea, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 37
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tacrolimus group tacrolimus Oral
- Primary Outcome Measures
Name Time Method Remission rate 24 weeks Percentage of the patients who shows complete remission or partial remission
- Secondary Outcome Measures
Name Time Method Change from baseline in urine protein to creatinine ratio Baseline, 4 weeks, 12 weeks and 24 weeks Safety assessed by the incidence of adverse events, abnormal findings of laboratory tests and vital signs for 24 weeks Complete remission rate 24 weeks Change from baseline in serum creatinine Baseline, 4 weeks, 12 weeks and 24 weeks