Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
NCT ID: NCT01042457
Last Updated: 2013-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2009-05-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mycophenolate mofetil
Mycophenolate mofetil
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Interventions
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Mycophenolate mofetil
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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.
Related to Treatment
* Previous of any Mycophenolate groups in the 3 months prior to screening.
* Treatment with more than 2 g Cyclophosphamide in the last 6 months period prior to screening.
* Receipt of more than 3 g IV pulse methylprednisolone within the last 3 months prior to screening.
* Receipt of prednisolone dose \> 30 mg/day for longer than 30 days within last 3 months prior to screening.
Related to General Health
* Pregnancy or breast feeding mothers.
* Evidence of significant uncontrolled concomitant disease in any organ system not related to SLE.
* History of cancer, including solid tumors, hematological malignancies and carcinoma.
* History of serious recurrent or chronic infection.
* Evidence of current abuse of drugs or alcohol.
Related to Laboratory Findings
* Neutrophile \< 1,500/mm3, Hb \< 7g/L, Platelet \< 50,000/mm3 (except active SLE)
* Positive HBsAg or anti-HCV or anti-HIV.
16 Years
60 Years
ALL
No
Sponsors
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Chulalongkorn University
OTHER
Responsible Party
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Principal Investigators
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Yingyos Avihingsanon, MD
Role: STUDY_DIRECTOR
Chulalongkorn University
Locations
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Chulalongkorn University
Bangkok, Bangkok, Thailand
Countries
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Related Links
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(Lupus Research Unit)
Other Identifiers
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2009-002
Identifier Type: -
Identifier Source: org_study_id