drugset / Trial / NCT01580865
Comparison Between Tacrolimus (TAC) and Mycophenolate Mofetil (MMF) for Induction of Remission in Lupus Nephritis
Completed
84 enrolled
Ramathibodi Hospital
Department of Medical Services Ministry of Public Health of Thailand · collabKing Chulalongkorn Memorial Hospital · collabMaharaj Nakorn Chiang Mai Hospital · collabSiriraj Hospital · collabSongklanagarind Hospital · collabSrinagarind Hospital, Khon Kaen University · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
Prospective, multi-center, randomized, controlled, trial to compare tacrolimus with mycophenolate mofetil (MMF) for induces complete remission in lupus nephritis patients. The study duration is one year. Research hypothesis * The proportion of patients who have achieved complete remission between regimen of tacrolimus plus prednisolone is greater than MMF plus prednisolone as an induction therapy in lupus nephritis.
Timeline
- Start
- 2012-05
- Primary completion
- 2017-03
- Completion
- 2017-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mycophenolate Mofetil | Small molecule | 750 mg | — |
| Subject | Mycophenolate Mofetil | Small molecule | 1000 mg | — |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | — |
| Background | Prednisolone | Other / unclassified | 5 mg | — |