Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis.

Study Overview
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Brief Summary
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The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.

Detailed Description
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Proliferative glomerulonephritis is a common and severe manifestation of systemic lupus erythematosus (SLE) that usually requires intensive therapy with high doses of glucocorticosteroids and cytotoxic drugs, such as intravenous (IV) cyclophosphamide (CYC). The objective of the MAINTAIN Nephritis Trial is to compare mycophenolate mofetil (MMF) and azathioprine (AZA), in terms of efficacy and toxicity, as remission-maintaining treatment of proliferative lupus glomerulonephritis, after a remission-inducing therapy with a short-course IV CYC regimen. The hypothesis addressed by the MAINTAIN Nephritis Trial is that MMF is superior to AZA.

Official Title
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A Randomized Multicenter Trial Comparing Mycophenolate Mofetil and Azathioprine as Remission-maintaining Treatment for Proliferative Lupus Glomerulonephritis. The MAINTAIN Nephritis Trial.

Conditions
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Lupus Nephritis

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: SLE aged ≥ 14 years Proteinuria ≥ 500 mg/day Biopsy-proven proliferative lupus nephritis Exclusion Criteria: Recent treatment with high-dose glucocorticoids Recent treatment with immunosuppressive drugs More exclusion criteria in the protocol

Ages Eligible for Study
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Minimum Age: 14 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: 1<br>Mycophenolate mofetil (target dose 2g/day) | Drug: Mycophenolate mofetil<br>* Mycophenolate mofetil<br>|
| Active Comparator: 2<br>Azathioprine (target dose 2mg/kg/day) | Drug: Azathioprine<br>* Azathioprine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to renal flare |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of withdrawals due to toxicity |  | 5 years and 10 years | 
| Cumulated glucocorticoid intake |  | 5 years and 10 years | 
| Number of treatment failures |  | 5 years and 10 years | 
| 24-hour proteinuria over time |  | 5 years and 10 years | 
| Serum creatinine titers |  | 5 years and 10 years | 
| Time to renal flare |  | 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine