The Effect of Mycophenolate Mofetil and Cyclophosphamide on the Lymphocyte Subsets in Patients With Proliferative Lupus Nephritis
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2028
December 16, 2024
December 1, 2024
11.8 years
September 13, 2016
December 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Lymphocyte subset profile (CD8+ T cells, CD4+ Th1, Th2, Th17 & Treg), Naïve & memory B cells, plasma cells
48 weeks
Secondary Outcomes (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)
48 weeks
Study Arms (2)
MMF-MMF
ACTIVE COMPARATORClass III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus mycophenolate mofetil (MMF) (1g bd) as induction-maintenance therapy
CTX-AZA
PLACEBO COMPARATORClass III/IV+V LN patients who receive prednisolone (PRED) (0.8mg/kg/d) plus Cyclophosphamide (CTX) (1.5-2mg/kg/d) followed by Azathioprine (AZA) (1-1.5mg/kg/d) as induction-maintenance therapy
Interventions
Eligibility Criteria
You may qualify if:
- \- 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.
- \. Willing to give informed consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Queen Mary Hospital
Hong Kong, Hong Kong
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2016
First Posted
November 4, 2016
Study Start
March 1, 2017
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2028
Last Updated
December 16, 2024
Record last verified: 2024-12