Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
- Registration Number
- NCT01172002
- Lead Sponsor
- RenJi Hospital
- Brief Summary
Leflunomide versus Azathioprine for Maintenance Therapy 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 this Trial is to compare leflunomide (LEF) 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 of this trial is that LEF is non-inferior to AZA.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Aged 18 to 65 years
- Biopsy-proven proliferative lupus nephritis
- Disease activity, SLEDAI score ≥ 8 points
- Persistent proteinuria (≥ 1g/24h), with or without microscopic hematuria;
- Signed informed consent
Exclusion Criteria
- Allergy to the LEF, CTX, AZA
- Recent treatment with high-dose glucocorticoids
- Weight <45kg
- Recent treatment with immunosuppressive drugs
- CNS( Central Nerve System) Lupus patients
- Hepatic failure patients
- Severely abnormal renal function or end-stage renal failure
- More exclusion criteria in the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Azathioprine group Azathioprine - leflunomide group Leflunomide -
- Primary Outcome Measures
Name Time Method lupus nephritis flare two years
- Secondary Outcome Measures
Name Time Method Serum albumin over time two years Number of extra renal flare two years Cumulated glucocorticoid intake two years 24-hour proteinuria over time two years
Trial Locations
- Locations (1)
RenJi Hospital
🇨🇳ShangHai, Shanghai, China