A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
Information source: Astellas Pharma Inc
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Lupus Nephritis
Intervention: tacrolimus capsule (Drug); tacrolimus placebo (Drug); leflunomide tablet (Drug); leflunomide placebo (Drug); prednisone (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s):
Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Overall contact:
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: remission rate (partial remission + complete remission)
Secondary outcome: urinary protein excretion for 24 hrs (24hr proteinuria)serum albumin level serum creatinine level estimated glomerular filtration rate (eGFR)
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Clinical Development Administration Dept., Email: clinicaltrials_info@jp.astellas.com
Beijing, China; Recruiting
Fujian, China; Recruiting
Hubei, China; Recruiting
Hunan, China; Recruiting
Jiangsu, China; Recruiting
Jilin, China; Recruiting
Liaoning, China; Recruiting
Shandong, China; Recruiting
Shanghai, China; Recruiting
Shanxi, China; Recruiting
Sichuan, China; Recruiting
Zhejiang, China; Recruiting
Additional Information
Starting date: April 2011
Last updated: October 10, 2011
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