Concentration-controlled Therapy of Mycophenolate Mofetil (MMF) in Proliferative Lupus Nephritis
This study has been completed.
Information provided by (Responsible Party):
First received: January 4, 2010
Last updated: September 27, 2013
Last verified: September 2013
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 ]
| Study Start Date:
| Study Completion Date:
| 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
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 4, 2010
||September 27, 2013
||Thailand: Ethical Committee
Keywords provided by Chulalongkorn University:
therapeutic drug monitoring
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 21, 2014
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Immune System Diseases
Physiological Effects of Drugs
Molecular Mechanisms of Pharmacological Action