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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: tacrolimus


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus group<br>Oral | Drug: tacrolimus<br>* oral<br>* Other names: FK506;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate | Percentage of the patients who shows complete remission or partial remission | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission rate |  | 24 weeks | 
| Change from baseline in urine protein to creatinine ratio |  | Baseline, 4 weeks, 12 weeks and 24 weeks | 
| Change from baseline in serum creatinine |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Prograf, FK506, Proteinuria, Calcineurin inhibitor