Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis

Study Overview
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Brief Summary
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To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Mycophenolate mofetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16-60 years. Ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (>90% chronic irreversible scarring) Exclusion Criteria: Relates to SLE Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR < 30 ml/min(except creatinine clearance or MDRD-GFR > 50 ml/min in the 12 weeks prior to screening) History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups. Related to Treatment Previous of any Mycophenolate groups in the 3 months prior to screening. Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening. Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening. Receipt of prednisolone dose > 30 mg/day for longer than 30 days within last 3 months prior to screening. Related to General Health Pregnancy or breast feeding mothers. Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE. History of cancer, including solid tumors, hematological malignancies and carcinoma. History of serious recurrent or chronic infection. Evidence of current abuse of drugs or alcohol. Related to Laboratory Findings Neutrophile < 1,500/mm3, Hb < 7g/L, Platelet < 50,000/mm3 (except active SLE) Positive HBsAg or anti-HCV or anti-HIV.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 60 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 |
| --- | --- |
| Other: Mycophenolate mofetil<br> | Drug: Mycophenolate mofetil<br>* Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.<br>* Other names: cellcept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine Mycophenolic acid level related side effect. |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trough level, therapeutic drug monitoring, Mycophenolate mofetil, Mycophenolic acid, lupus nephritis