The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MMF-MMF, CTX-AZA.
- Who it may be relevant to
- Registry conditions: Lupus Nephritis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets and Relationship With Relapse
Overview
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.
Detailed description
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.
Interventions
- 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
Primary outcome measures
- Lymphocyte subset profile (CD8+ T cells, CD4+ Th1, Th2, Th17 & Treg), Naïve & memory B cells, plasma cells [Time frame: 48 weeks]
Secondary outcome measures (1)
- serum cytokine profile (IL-2, IL-5, IL-6, IL-7, IL-10, IL-17, IL-21, IL-23, IFN-alpha, IFN-gamma, TGF-beta) [Time frame: 48 weeks]
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
- Patients who have received calcineurin inhibitors or proliferation signal inhibitors as maintenance immunosuppression in the preceding 3 months
- Patients have received biologics therapy (e.g. rituximab, abatacept) in the preceding 12 months
- Patients who are pregnant or lactating
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Hong Kong · 1 center
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT02954939 · UW12-389