RECRUITINGINTERVENTIONAL

The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis

The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: \- 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 willing to sign a consent form Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DRUG

MMF-MMF

Class III/IV+/-V lupus nephritis patients to receive PRED+MMF

DRUG

CTX-AZA

Class III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA

Locations (1)

Queen Mary Hospital

Hong Kong, Hong Kong