The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
Summary
This study investigated the effect of mycophenolate mofetil and cyclosphosphamide on lymphocyte subsets in patients with proliferative lupus nephritis. Patients with biopsy-proven Class III/IV+/-V LN were randomized to received: 1) prednisolone (0.8mg/kg/day) plus CTX (1.5-2mg/kg/d) for 6 months) followed by Azathioprine (AZA) (1-1.5mg/kg/d) maintenance; OR 2) prednisolone (0.8mg/kg/d) plus MMF (1g bd) for 6 months, followed by MMF (tapered according to clinical status) as maintenance. The lymphocyte subsets and serum cytokine profiles will be measured at 4-, 12-, and 24-, 36- and 48 weeks after induction treatment. The lymphocyte subsets and serum cytokine profiles will be compared between the two treatment regimens, and also correlated with subsequent risk of relapse.
Timeline
- Start
- 2017-03-01
- Primary completion
- 2028-12-31
- Completion
- 2028-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azathioprine | Small molecule | 1 mg/kg | — |
| Comparator | Azathioprine | Small molecule | 1.5 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 1.5 mg/kg | — |
| Comparator | Cyclophosphamide | Other / unclassified | 2 mg/kg | — |
| Comparator | Mycophenolate Mofetil | Small molecule | 1 g | — |
| Comparator | Prednisolone | Other / unclassified | 0.8 mg/kg | — |