Lupus Nephritis
Conditions
Keywords
Lupus nephritis, Treatment, Maintenance therapy, Mycophenolate mofetil, Azathioprine
Brief summary
The purpose of the study is to determine whether mycophenolate mofetil is superior to azathioprine to prevent flares of lupus nephritis.
Detailed description
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.
Interventions
DRUGMycophenolate mofetil
Mycophenolate mofetil
DRUGAzathioprine
Azathioprine
Sponsors
Frédéric A. Houssiau, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to renal flare | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Cumulated glucocorticoid intake | 5 years and 10 years |
| Number of treatment failures | 5 years and 10 years |
| Number of withdrawals due to toxicity | 5 years and 10 years |
| Serum creatinine titers | 5 years and 10 years |
| Time to renal flare | 10 years |
| 24-hour proteinuria over time | 5 years and 10 years |
Countries
Belgium
Outcome results
None listed