A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
NCT ID: NCT01342016
Last Updated: 2014-10-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
84 participants
INTERVENTIONAL
2011-04-30
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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tacrolimus group
tacrolimus capsule + leflunomide placebo
tacrolimus capsule
oral
leflunomide placebo
oral
prednisone
oral
leflunomide group
tacrolimus placebo + leflunomide tablet
tacrolimus placebo
oral
leflunomide tablet
oral
prednisone
oral
Interventions
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tacrolimus capsule
oral
tacrolimus placebo
oral
leflunomide tablet
oral
leflunomide placebo
oral
prednisone
oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
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Astellas Pharma China, Inc.
INDUSTRY
Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Use Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Beijing, , China
Fujian, , China
Hubei, , China
Hunan, , China
Jiangsu, , China
Jilin, , China
Liaoning, , China
Shandong, , China
Shanghai, , China
Shanxi, , China
Sichuan, , China
Zhejiang, , China
Countries
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Other Identifiers
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F506-CL-0911
Identifier Type: -
Identifier Source: org_study_id
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