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

Astellas

Status and phase: Terminated; Phase 3

Conditions: Lupus Nephritis

Treatments: Drug: tacrolimus capsule; Drug: leflunomide tablet; Drug: leflunomide placebo; Drug: prednisone; Drug: tacrolimus placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342016

F506-CL-0911

Details and patient eligibility

About

The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.

Enrollment: 84 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 2 patient groups

tacrolimus group

Experimental group

Description:

tacrolimus capsule + leflunomide placebo

Treatment:

Drug: leflunomide placebo

Drug: prednisone

Drug: tacrolimus capsule

leflunomide group

Active Comparator group

Description:

tacrolimus placebo + leflunomide tablet

Treatment:

Drug: tacrolimus placebo

Drug: leflunomide tablet

Drug: prednisone