Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis
NCT02630628 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2025-09-25
Summary
Prospective, randomized, parallel-group controlled, open-label, international (Asian) multicenter, comparison of corticosteroids combined with tacrolimus and corticosteroids combined with mycophenolate mofetil.
Conditions
Interventions
- DRUG
-
Dosage: start at 2mg twice a day, then titrated according to therapeutic drug level monitoring using 12-hour post-dose blood sampling
- DRUG
-
Mycophenolate mofetil
Dosage: start at 1g twice a day, then taper as per protocol
Sponsors & Collaborators
-
The University of Hong Kong
lead OTHER
Principal Investigators
-
Tak-Mao Daniel Chan · The University of Hong Kong
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-12-05
- Primary Completion
- 2024-12-27
- Completion
- 2024-12-27
Countries
- Hong Kong
Study Locations
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