Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Chulalongkorn University.
Recruitment status was Recruiting
Information provided by:
First received: January 4, 2010
Last updated: April 19, 2011
Last verified: April 2011
To evaluate therapeutic response to MMF treatment in patients with International Society of Nephrology/Renal Pathology Society (ISN/RPS) class III or IV lupus nephritis. Mycophenolic acid levels at 1-hour post dose will be monitored monthly up to 6 months.
Drug: Mycophenolate mofetil
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- Response rate of Mycophenolic acid concentration-controlled therapy in active lupus nephritis patients at 6th month [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine Mycophenolic acid level related side effect. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2011 (Final data collection date for primary outcome measure)
Drug: Mycophenolate mofetil
Drug : Mycophenolate Mofetil. Starting doses : 1000-1500 mg/day with titration based on Mycophenolic 1-hour post dose level.
Other Name: cellcept
|Ages Eligible for Study:
||16 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Age 16-60 years.
- 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)
Relates to SLE
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042457
|Bangkok, Thailand |
||Yingyos Avihingsanon, MD
No publications provided
||Yingyos Avihingsanon, Chulalongkorn University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2010
||April 19, 2011
||Thailand: Ethical Committee
Keywords provided by Chulalongkorn University:
therapeutic drug monitoring
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action