Study Stopped
Data Safety Monitoring Board concerning of the participants' safety
The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
CONTROL
The Clinical Efficacy and Economic Evaluation of EC-MPS (Myfortic) in the Treatment of Relapse or Resistant Proliferative Lupus Nephritis
4 other identifiers
interventional
59
1 country
3
Brief Summary
To investigate the efficacy and safety of enteric-coated mycophenolate sodium (Myfortic) as compared to intravenous cyclophosphamide in the treatment of active nephritis. The primary outcomes are complete and partial renal remission, as assessed by renal function, urinary sediment and proteinuria in patients with International Society of Nephrology/ Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2010
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedOctober 10, 2014
October 1, 2014
3 years
November 17, 2009
October 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Efficacy of enteric-coated Mycophenolate Sodium at 12 months in the treatment of lupus nephritis
12 months
Secondary Outcomes (3)
The cost-effectiveness of using enteric-coated Mycophenolate Sodium as compared to standard treatment
12 months
The ratio of patients with declined renal function
12 months
Time to remission
12 months
Study Arms (2)
1
EXPERIMENTALOral mycophenolate sodium 1440 mg per day for 12 months
2
ACTIVE COMPARATORIntravenous cyclophosphamide monthly for 6 months
Interventions
Eligibility Criteria
You may qualify if:
- age 16 years of above at the time of screening
- ability and willingness to provide written informed consent (or to obtain consent from parent guardian where applicable) and to comply with the schedule of protocol requirements
- Diagnosis of SLE according to ACR criteria. At least 4 criteria must have been present for the diagnosis of SLE. The 4 criteria do not have to be present at the time of screening
- Active lupus nephritis defined as follows: Biopsy proven (within 16 weeks prior to screening) ISN Class III or IV (A or A/C) not include III(C) IV(C) and VI (\>90% chronic irreversible scarring)
- Relapse or resistant to (3 consecutive doses) IVCY
- Resistant lupus or Relapse lupus nephritis defined as follows:
- Increase in serum creatinine \>/= 0.3 mg/dl or
- Increase in proteinuria \> 1.5 g/day (which must have improved by ≥ 50% in the preceding 3 months)
- Life-time cumulative dose of IVCY \> 6 grams
- Female patients of childbearing potential must have a negative serum pregnancy
You may not qualify if:
- Relates to SLE
- Diagnosis of rapid progressive glomerulonephritis (RPGN): doubling serum creatinine and/or crescentic glomeruli ≥ 30%
- Severe renal impairment as defined by calculated creatinine clearance or MDRD-GFR \< 30 ml/min(except creatinine clearance or MDRD-GFR \> 50 ml/min in the 12 weeks prior to screening)
- History of serious disease or complication in any organ system that not appropriate to treatment immunosuppressive drug groups.
- Severe extra-renal organ involvement
- Related to Treatment
- Previous of any Mycophenolate groups in the 6 months prior to screening
- Treatment with any investigational drugs in the 3 months prior to screening
- Related to General Health
- Pregnancy or breast feeding mothers.
- Concomitant condition which has required treatment moderate to high dose steroid in the 12 weeks prior to screening.
- Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
- History of cancer, including solid tumors, hematological malignancies and carcinoma.
- Evidence of current abuse of drugs or alcohol.
- Related to Laboratory Findings
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Khon Kaen University
Khon Kaen, Changwat Khon Kaen, Thailand
Nopparat Rajathani
Bangkok, Thailand
Thammasart University
Pathum Thani, Thailand
Related Publications (1)
Anutrakulchai S, Panaput T, Wongchinsri J, Chaishayanon S, Satirapoj B, Traitanon O, Pima W, Rukrung C, Thinkhamrop B, Avihingsanon Y. A multicentre, randomised controlled study of enteric-coated mycophenolate sodium for the treatment of relapsed or resistant proliferative lupus nephritis: an Asian experience. Lupus Sci Med. 2016 Jan 14;3(1):e000120. doi: 10.1136/lupus-2015-000120. eCollection 2016.
PMID: 26835147DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yingyos Avihingsanon, MD
Chulalongkorn University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor.
Study Record Dates
First Submitted
November 17, 2009
First Posted
November 18, 2009
Study Start
January 1, 2010
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
October 10, 2014
Record last verified: 2014-10