Actively Recruiting
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
Led by The University of Hong Kong · Updated on 2024-12-16
50
Participants Needed
1
Research Sites
617 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with biopsy proven Class III/IV+/-V lupus nephritis (ISN/RPS classification) and active nephritis shown by proteinuria >1g/day and/or serum creatinine rise >15% from baseline, with or without serological reactivation
- Willing to give informed consent
You will not qualify if you...
- Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
- Patients who have received biologic therapy (e.g., rituximab, abatacept) in the preceding 12 months
- Patients who are pregnant or lactating
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Queen Mary Hospital
Hong Kong, Hong Kong
Actively Recruiting
Research Team
D
Desmond YAP, MD (HK)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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