Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

Study Overview
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Brief Summary
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This is a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) for the induction therapy of Lupus Nephritis (LN) (V, III +V, IV+V).

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: ADVAGRAF


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects of either sex, 14-65 years of age; Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997); Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V; LN (Class IV+V): proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), > 5 red blood cell count (RBC)/hpf; LN (Class V or III +V ): proteinuria > 2g/24hr or Scr > 1.3 mg/dl; Provision of written informed consent by subject or guardian Exclusion Criteria: Inability or unwillingness to provide written informed consent Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment Scr > 4mg/dl (354umol/L) Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin Lupus encephalopathy Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma) History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study Any Active systemic infection or history of serious infection within one month of entry known infection with HIV, hepatitis B, or hepatitis C Known hypersensitivity or contraindication to tacrolimus, corticosteroids Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening Pregnancy, nursing or use of a non-reliable method of contraception.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 65 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADVAGRAF<br>Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase for 6 months | Drug: ADVAGRAF<br>* Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.<br>* Other names: ADVAGRAF:Tacrolimus Sustained-release Capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (complete or partial remission) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria |  | every 3 months,up to 6 months | 
| Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores | SLEDAI (Systemic Lupus Erythematosus Disease Activity Index, Bombardier et al, 1992). | every 3 months, up to 6 months | 
| Number of participants with adverse events as a measure of safety and tolerability | Adverse events,including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc. | every 3 months, up to 6 months | 
| renal function |  | every 3 months, up to 6 months | 
| relapse |  | every 3 months, up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus Nephritis, Tacrolimus, Induction Phase