A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
NCT02457221 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 314
Last updated 2024-11-01
Summary
The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
Conditions
Interventions
- DRUG
-
Tacrolimus capsules
oral
- DRUG
-
Cyclophosphamide injections
intravenous injection
- DRUG
-
oral
Sponsors & Collaborators
-
Astellas Pharma China, Inc.
lead INDUSTRY
Principal Investigators
-
Medical Director · Astellas Pharma China, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-03-10
- Primary Completion
- 2018-09-10
- Completion
- 2018-09-10
Countries
- China
Study Locations
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