Mycophenolate Mofetil vs Cyclophosphamide for Lupus Nephritis
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
Recruiting
N/AInterventional Study
Lupus Nephritis
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At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Basic Science
Participants needed
50 (estimated)
Sponsor
The University of Hong Kong · Other
Who this trial is looking for
This trial is looking for patients with a specific type of kidney inflammation due to lupus. Participants will receive different treatments for 6 months, and their immune system responses will be monitored.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with lupus nephritis.
I have active kidney issues shown by high protein in my urine or increased creatinine.
I am willing to give informed consent.
You may not be able to join if
I have taken certain immunosuppressive medications in the last 3 months.
I have received biologic treatments in the last 12 months.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 (1…
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.
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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…
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
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