Trials / Completed
CompletedNCT02457221
A Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
A Phase III, Randomized, Open, Parallel-controlled, Multi-center Study to Compare the Efficacy and Safety of Tacrolimus Capsules and Cyclophosphamide Injection in Treatment of Lupus Nephritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 314 (actual)
- Sponsor
- Astellas Pharma China, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
This is a randomized, open, 1:1 parallel controlled, multi-center, non-inferiority clinical study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tacrolimus capsules | oral |
| DRUG | Cyclophosphamide injections | intravenous injection |
| DRUG | Prednisone | oral |
Timeline
- Start date
- 2015-03-10
- Primary completion
- 2018-09-10
- Completion
- 2018-09-10
- First posted
- 2015-05-29
- Last updated
- 2024-11-01
Locations
35 sites across 1 country: China
Source: ClinicalTrials.gov record NCT02457221. Inclusion in this directory is not an endorsement.