Study to Assess the Efficacy and Safety of FK506 Combined With Mycophenolate Mofetil (MMF) in Lupus Nephritis (III/IV/V)

Study Overview
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Brief Summary
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This is an open, prospective study to assess the efficacy and safety of Tacrolimus (FK506) combined with MMF in the treatment of class III, IV, V + IV or V + III lupus nephritis.

Detailed Description
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To assess the efficacy of FK506 combined with MMF vs intravenous CTX pulses in treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. To investigate the safety and tolerability of FK506 combined with MMF vs intravenous CTX pulses in the treatment of class Ⅲ, Ⅳ, Ⅴ + Ⅳ or Ⅴ + Ⅲ LN. To explore the dosing of FK506 combined with MMF and their effective range of blood concentration.

Official Title
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An Open, Prospective Study to Assess the Efficacy and Safety of FK506 Combined MMF in the Treatment of Class III，IV，V + IV or V + III Lupus Nephritis

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Multitherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female patients with a diagnosis of systemic lupus erythematosus (SLE) according to the criteria of American Rheumatic Association, 1982, aged between 12-50 years, with score of SLE-DAI (Disease Active Index) of more than 12 (not including class V LN). Patients diagnosed according to ISN/RPS 2003 classification criteria: class Ⅲ, Ⅳ, Ⅳ + Ⅴ, Ⅲ + Ⅴ LN by renal biopsy within 3 months, CI< 4，Scr< 3 mg/dl. Patients with a proteinuria ≥ 1.5 g/24h, or active urine sediment. Patients who signed written informed consent forms (patients less than 18 years old with their parents/legal representative' signatures), and have given their consent to follow all study procedures and follow-ups. Exclusion Criteria: Patients who have received treatment of cytotoxic drugs such as cyclophosphamide (CTX), cyclosporine A for more than 1 week within three months. Patients with serum creatinine ≥ 3 mg/dl（265 μmol/L). Patients with severe infection or central nervous system symptoms. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis. Patients who have abnormal blood glucose, with a fasting blood glucose > 6.2 mmol/L or post meal blood glucose > 11.2 mmol/L. Patients who are pregnant or lactating. Patients who are known to be allergic to a macrolide.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FK506+MMF<br> | Drug: Multitherapy<br>* Tacrolimus,4mg/d, MMF 1.0g/d<br>* Other names: MMF,cellcept,mycophenolate mofetil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of FK506 combined with MMF versus intravenous CTX pulses in treatment of LN |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the safety and tolerability of FK506 combined with MMF versus intravenous CTX pulses |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tacrolimus, Mycophenolate mofetil, Cyclophosphamide, Lupus nephritis, Treatment