A Study to Compare the Efficacy and Safety of Tacrolimus Capsules With Leflunomide Tablets in Lupus Nephritis Patients
NCT01342016 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2014-10-17
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.
Conditions
Interventions
- DRUG
-
tacrolimus capsule
oral
- DRUG
-
tacrolimus placebo
oral
- DRUG
-
leflunomide tablet
oral
- DRUG
-
leflunomide placebo
oral
- DRUG
-
oral
Sponsors & Collaborators
-
Astellas Pharma China, Inc.
collaborator INDUSTRY -
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Inc
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-04-30
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- China
Study Locations
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