Lupus Nephritis
Conditions
Keywords
Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine, Spot urine protein/creatinine ratio
Brief summary
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
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.
Interventions
DRUGMycophenolate mofetil
Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
DRUGAzathioprine
Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
DRUGPrednisolone
Daily dose not more than 10mg, orally, for 24 weeks.
Sponsors
Genovate Biotechnology Co., Ltd.,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in spot urine protein/creatinine ratio | 24 weeks treatment |
| Change in serum albumin | 24 weeks treatment |
| Change in serum creatinine | 24 weeks treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in spot urine protein/creatinine ratio | 12 weeks treatment |
| Change in the average daily dose of oral prednisolone | 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 cholesterol | 24 weeks treatment |
| Change in serum albumin | 12 weeks treatment |
| Change in serum creatinine | 12 weeks treatment |
Outcome results
None listed