Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Study Overview
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Brief Summary
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This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.

Detailed Description
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This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.

Official Title
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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Conditions
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Lupus Nephritis

Intervention / Treatment
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* Drug: Mycophenolate mofetil
* Drug: Azathioprine
* Drug: Prednisolone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of lupus nephritis. Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization. Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization. Exclusion Criteria: Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis. Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids. Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks. Previous kidney transplant or planned transplant. Presence of life threatening complications such as cerebral lupus or severe infection. Presence of liver dysfunction. Presence of COPD or asthma requiring oral steroids. Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus. Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MMF 500mg<br>Mycophenolate mofetil 500mg, PO BID | Drug: Mycophenolate mofetil<br>* Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.<br>* Other names: Mycocep Capsules;Drug: Prednisolone<br>* Daily dose not more than 10mg, orally, for 24 weeks.<br>|
| Experimental: MMF 750mg<br>Mycophenolate mofetil 750mg, PO BID | Drug: Mycophenolate mofetil<br>* Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.<br>* Other names: Mycocep Capsules;Drug: Prednisolone<br>* Daily dose not more than 10mg, orally, for 24 weeks.<br>|
| Active Comparator: AZA<br>Azathioprine 1mg/kg, PO BID | Drug: Azathioprine<br>* Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.<br>* Other names: Imuran Azathioprine Tablets;Drug: Prednisolone<br>* Daily dose not more than 10mg, orally, for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum albumin |  | 24 weeks treatment | 
| Change in serum creatinine |  | 24 weeks treatment | 
| Change in spot urine protein/creatinine ratio |  | 24 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum albumin |  | 12 weeks treatment | 
| Change in serum creatinine |  | 12 weeks treatment | 
| Change in spot urine protein/creatinine ratio |  | 12 weeks treatment | 
| Change in cholesterol |  | 24 weeks treatment | 
| Change in triglyceride |  | 24 weeks treatment | 
| Change in complete blood count/differential count (CBC/DC) |  | 24 weeks treatment | 
| Change in number of subjects with doubling of serum creatinine |  | 24 weeks treatment | 
| Change in the average daily dose of oral prednisolone |  | 24 weeks treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine, Spot urine protein/creatinine ratio