Trials / Completed
CompletedNCT02949349
Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Genovate Biotechnology Co., Ltd., · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
Detailed description
This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day \& 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mycophenolate mofetil | Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks. |
| DRUG | Azathioprine | Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks. |
| DRUG | Prednisolone | Daily dose not more than 10mg, orally, for 24 weeks. |
Timeline
- Start date
- 2015-07-01
- Primary completion
- 2016-12-30
- Completion
- 2017-01-25
- First posted
- 2016-10-31
- Last updated
- 2017-03-03
Source: ClinicalTrials.gov record NCT02949349. Inclusion in this directory is not an endorsement.