Leflunomide Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Study Overview
=================
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.

Official Title
-----------------
A Randomized Multicenter Trial Comparing Leflunomide and Azathioprine as Remission-Maintaining Treatment for Proliferative Lupus Glomerulonephritis.

Conditions
-----------------
Nephritis, Lupus

Intervention / Treatment
-----------------
* Drug: Leflunomide
* Drug: Azathioprine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: leflunomide group<br> | Drug: Leflunomide<br>* 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.<br>|
| Active Comparator: Azathioprine group<br> | Drug: Azathioprine<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lupus nephritis flare |  | two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus Nephritis, Leflunomide, Azathioprine