Lupus, Nephritis
Conditions
Keywords
Lupus Nephritis, Leflunomide, Azathioprine
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.
Interventions
DRUGLeflunomide
Leflunomide, 20 mg/d, ORAL ,each day. Number of Cycles: until progression or unacceptable toxicity develops. Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.
DRUGAzathioprine
Azathioprine,50-100 mg/d, ORAL ,each day . Number of Cycles: until progression or unacceptable toxicity develops. Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks.
Sponsors
Changhai Hospital
Shanghai 10th People's Hospital
Shanghai Zhongshan Hospital
The First Affiliated Hospital with Nanjing Medical University
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
The First Affiliated Hospital of Soochow University
Zhejiang University
Second Affiliated Hospital, School of Medicine, Zhejiang University
First Affiliated Hospital of Wenzhou Medical University
Qilu Hospital of Shandong University
AnHui ShengLi Hospital
The First Affiliated Hospital of Bengbu Medical University
The First Affiliated Hospital of Anhui Medical University
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| lupus nephritis flare | two years |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour proteinuria over time | two years |
| Serum albumin over time | two years |
| Number of extra renal flare | two years |
| Cumulated glucocorticoid intake | two years |
Countries
China
Contacts
Primary ContactBao Chun De
Outcome results
None listed