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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MMF 500mg | Experimental | Mycophenolate mofetil 500mg, PO BID |
|
| MMF 750mg | Experimental | Mycophenolate mofetil 750mg, PO BID |
|
| AZA | Active Comparator | Azathioprine 1mg/kg, PO BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mycophenolate mofetil | Drug | Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Han Chen, M.D., Ph.D. | Taipei Veterans General Hospital, Taiwan, R.O.C. | Principal Investigator |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D009173 | Mycophenolic Acid |
| D001379 | Azathioprine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Azathioprine | Drug | Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks. |
|
|
| Prednisolone | Drug | Daily dose not more than 10mg, orally, for 24 weeks. |
|
| 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 |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D005227 |
| Fatty Acids |
| D008055 | Lipids |
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D015122 | Mercaptopurine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |