The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
This study compares two different drug treatments for lupus nephritis, a serious kidney condition caused by lupus. Researchers examined how mycophenolate mofetil and cyclophosphamide affect immune cells in the blood of patients with this condition.
Key Objective:This trial tests whether mycophenolate mofetil or cyclophosphamide can better control the immune system and protect kidney function in patients with proliferative lupus nephritis.
Who to Consider:Patients with biopsy-confirmed proliferative lupus nephritis (Class III/IV with or without Class V) who are willing to be randomly assigned to receive one of two different immunosuppressive treatment regimens should consider enrolling.
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: \- 1. Patients with biopsy proven Class III/IV+/-V LN (ISN/RPS classification) and active nephritis as indicated by an increase of proteinuria \>1g/day and/or rise in serum creatinine by \>15% compared with baseline, with or without serological reactivation. 2\. Willing to give informed consent Exclusion Criteria: 1. Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months 2. Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months 3. Patients who are pregnant or lactating