A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

Official Title
-----------------
A Randomized, Double-blind Double Dummy, Parallel Control and Multi-center Clinical Trial to Compare the Efficacy and Safety of Tacrolimus Capsules in Treatment of Lupus Nephritis With Leflunomide Tablets

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

Intervention / Treatment
-----------------
* Drug: tacrolimus capsule
* Drug: tacrolimus placebo
* Drug: leflunomide tablet
* Drug: leflunomide placebo
* Drug: prednisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body weight 40-100kg diagnosed as systemic lupus erythematosus, (according to American College of Rheumatology Diagnostic Criteria,1997) diagnosed as type III/ IV of lupus nephritis by renal biopsy within 6 months 24hr proteinuria ≥2g and/or active urinary sediments Exclusion Criteria: receiving immunosuppressant receiving routine treatment of tacrolimus and leflunomide within 1 month receiving nonsteroidal anti-inflammatory drugs (NSAIDs) within 1 months before the study history of allergy to tacrolimus and leflunomide anticipated maintenance dialysis persisted over 8 weeks; or already being dialyzed over 2 weeks before recruitment planning to receive kidney transplantation or in the near future or having a history of undergoing kidney transplantation serum creatinine (Scr) ≥3mg/dl or estimated glomerular filtration rate (eGFR) < 30ml/min diabetes mellitus patients

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tacrolimus group<br>tacrolimus capsule + leflunomide placebo | Drug: tacrolimus capsule<br>* oral<br>* Other names: FK506;Drug: leflunomide placebo<br>* oral<br>Drug: prednisone<br>* oral<br>|
| Active Comparator: leflunomide group<br>tacrolimus placebo + leflunomide tablet | Drug: tacrolimus placebo<br>* oral<br>Drug: leflunomide tablet<br>* oral<br>* Other names: airuohua;Drug: prednisone<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| remission rate (partial remission + complete remission) |  | at 6 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urinary protein excretion for 24 hrs (24hr proteinuria) |  | at 12 weeks and 24 weeks | 
| serum albumin level |  | at 12 weeks and 24 weeks | 
| serum creatinine level |  | at 12 weeks and 24 weeks | 
| estimated glomerular filtration rate (eGFR) |  | at 12 weeks and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prograf, nephritis, leflunomide, immunosuppressant